Who else makes this device?

Name: Plateletworks Combo-10 Kit
Brand: Plateletworks Combo-10 Kit

Hematology › Automated Hematology DevicesSystem, Automated Platelet Aggregation

Plateletworks Combo-10 Kit

Catalogue number 5854, listed by Helena Laboratories, Corp., United States, under System, Automated Platelet Aggregation. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

4510(k) clearances naming this product code

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JOZ
Manufacturer	City	Province	Registered as	Device types
Zhejiang Gongdong Medical Technology Co., Ltd.	Taizhou	Zhejiang	Contract manufacturer	40

Record

Regulatory record for Plateletworks Combo-10 Kit
Listed by	Helena Laboratories, Corp., United States
FDA product code	JOZ
Device type	System, Automated Platelet Aggregation
Device class	Class 2
Regulation	21 CFR 864.5700
Establishment	Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K023761
Record published	2016-09-07
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Plateletworks Combo-10 Kit
Catalogue number	Size	Status
5854		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
VerifyNow System	Accriva Diagnostics, Inc.	12
Chrono-log	Chrono-LOG Corp.	10
TEG6s Hemostasis System	Haemonetics Corporation	5
VerifyNow Platelet Reactivity Test	Accriva Diagnostics, Inc.	4
TEG Hemostasis System	Haemonetics Corporation	3
TEG5000 Hemostasis System	Haemonetics Corporation	3
AggRecetin	Bio/Data Corp.	2
Aggreguide	Aggredyne, Inc.	2
Plateletworks Combo-25 Kit	Helena Laboratories, Corp.	1
Epinephrine	Bio/Data Corp.	1
Bapa tube	Zacros Corporation	1
T-TAS 01 Total Thrombus Formation Analysis System	Zacros Corporation	1

Showing 12 of 34. All products under System, Automated Platelet Aggregation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K023761	2003-02-14
K012723	2001-09-28
K851669	1985-07-23
K800432	1980-03-25

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.