Who else makes this device?

Name: HemataSTAT II Centrifuge
Brand: HemataSTAT II Centrifuge

Hematology › Manual Hematology DevicesCentrifuge, Hematocrit

HemataSTAT II Centrifuge

HemataStat II Microhematocrit System is a small, lightweight centrifuge which provides a rapid and accurate mircohematocrit determination using capillary or venous blood samples.

Registry build 21.09.26

4manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1), Hunan (1).

Chinese manufacturers registered for FDA product code GKG
Manufacturer	City	Province	Registered as	Device types
Hospital & Homecare IMP. & EXP. Co., Ltd.	Nanjing	Jiangsu	Contract manufacturer	179
Guangzhou Four E’s Scientific Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	61
Hunan Xiang YI Laboratory Instrument Development Co., Ltd.	Changsha	Hunan	Manufacturer	7
Zhejiang Huawei Scientific Instrument Co Ltd	Linhai	Zhejiang	Manufacturer	4

Record

Regulatory record for HemataSTAT II Centrifuge
Listed by	Separation Technology, Inc., United States
FDA product code	GKG
Device type	Centrifuge, Hematocrit
Device class	Class 2
Regulation	21 CFR 864.6400
Premarket notification	Exempt
Record published	2017-08-25
Record revised	2022-06-10 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number
Storage	Storage environment temperature -10 to 60 °C

Catalogue Numbers

Catalogue numbers for HemataSTAT II Centrifuge
Catalogue number	Size	Status
100-100		In distribution
100-133		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bucket	Andreas Hettich Gmbh	12
Angle rotor	Andreas Hettich Gmbh	11
Swing-out rotor	Andreas Hettich Gmbh	6
LW Scientific, Inc.	LW Scientific, Inc.	5
Globe Scientific	Globe Scientific, LLC	4
QBC Diagnostics	Drucker Diagnostics, LLC	2
Combo V24T Centrifuge,12-pl test tube and 24-pl hematocrit rotors w/ tach, 110v	LW Scientific, Inc.	2
Unico Powerspin BX	United Products & Instruments, Inc.	2
Combo V24 Centrifuge,12-place test tube and 24-place hematocrit rotors, 220v	LW Scientific, Inc.	2
CC Cartridge	LifeHealth, LLC	2
E8 Combination Centrifuge, digital	LW Scientific, Inc.	2
Henry Schein	Henry Schein, Inc.	2

Showing 12 of 37. All products under Centrifuge, Hematocrit

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K913128	1991-09-23
K890849	1989-03-21

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.