The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc., Clinical Systems Divis with the FDA for Variant(tm) Ii Turbo Hba1c Kit - 2.0.
| Device ID | K130990 |
| 510k Number | K130990 |
| Device Name: | VARIANT(TM) II TURBO HBA1C KIT - 2.0 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS 4000 ALFRED NOBEL DRIVE Hercules, CA 94547 |
| Contact | Ebony Mckinnies |
| Correspondent | Ebony Mckinnies BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS 4000 ALFRED NOBEL DRIVE Hercules, CA 94547 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-10 |
| Decision Date | 2013-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817014369 | K130990 | 000 |