The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Variant Ii Turbo Hba1c Kit Kit-20 And Wash/diluent Solution Set, Models 270-2455, 270-2730.
Device ID | K090699 |
510k Number | K090699 |
Device Name: | VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 |
Classification | Assay, Glycosylated Hemoglobin |
Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR Hercules, CA 94547 |
Contact | Jackie H Buckley |
Correspondent | Jackie H Buckley BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR Hercules, CA 94547 |
Product Code | LCP |
CFR Regulation Number | 864.7470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-17 |
Decision Date | 2009-07-27 |
Summary: | summary |