The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Bio-rad Variant Nbs Sickle Cell Program.
| Device ID | K051072 |
| 510k Number | K051072 |
| Device Name: | BIO-RAD VARIANT NBS SICKLE CELL PROGRAM |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | William G Gustafson |
| Correspondent | Alfred J Quattrone CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 997 413 FDB MAILSTOP 7602 Sacramento, CA 95899 -7413 |
| Product Code | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-04-26 |
| Decision Date | 2005-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817008351 | K051072 | 000 |
| 00847817008344 | K051072 | 000 |
| 00847817008313 | K051072 | 000 |
| 00847817008306 | K051072 | 000 |
| 00847817008283 | K051072 | 000 |
| 00847817008276 | K051072 | 000 |
| 00847817007354 | K051072 | 000 |