Who else makes this device?

Name: hemochroma Plus Optical System Check
Brand: hemochroma Plus Optical System Check

Hematology › Automated Hematology DevicesSystem, Hemoglobin, Automated

Hemochroma Plus Optical System Check

hemochroma PLUS Optical System Check is intended to assure the performance of the optic system of the hemochroma PLUS Analyzer.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(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 GKR
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29

Record

Regulatory record for hemochroma Plus Optical System Check
Listed by	Immunostics, Inc., United States
FDA product code	GKR
Device type	System, Hemoglobin, Automated
Device class	Class 2
Regulation	21 CFR 864.5620
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2018-12-20
Record revised	2025-03-31 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 35 °C

Catalogue Numbers

Catalogue numbers for hemochroma Plus Optical System Check
Catalogue number	Size	Status
100-404		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
RAPIDPoint® 405/500 Measurement Cartridge	Siemens Healthcare Diagnostics Inc	8
McKesson	Mckesson Medical-Surgical Inc.	6
HemoCue® Hb 301 Microcuvettes	Hemocue AB	5
HemoCue® Hb 201 Microcuvettes	Hemocue AB	4
Henry Schein	Henry Schein, Inc.	4
Mission Plus Hemoglobin (Hb) Monitoring System	Acon Laboratories, Inc.	3
Mission Plus Hemoglobin (Hb) Test Cartridges	Acon Laboratories, Inc.	3
DiaSpect Tm	EKF Diagnostic Gmbh	2
HemoCue® Hb 201+ Analyzer	Hemocue AB	2
Mission Capillary Transfer Tubes	Acon Laboratories, Inc.	2
Mission Plus Hemoglobin (Hb) Optical Verifier	Acon Laboratories, Inc.	2
HemoCue® Hb301 Analyzer	Hemocue AB	2

Showing 12 of 43. All products under System, Hemoglobin, Automated

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K182298	2018-11-16
K163465	2017-09-08

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.