SC90

Sensor cassette SC90 300BG, LYT, MET, OXI + QC for ABL90. 30

Registry build 21.09.26
1manufacturer
1catalogue number

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 SC90
Listed by Radiometer Medical APS, Denmark
FDA product code GKR
Device type System, Hemoglobin, Automated
Device class Class 2
Regulation 21 CFR 864.5620
Establishment Complaint-file establishment, Manufacturer
510(k) K240998
Record published 2026-07-09

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment humidity 20 to 80 % RH; Special storage condition: Keep away from sunlight; Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for SC90
Catalogue number Size Status
946-105 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer