The following data is part of a premarket notification filed by Bio-rad with the FDA for Variant Ii B-thalassemia.
| Device ID | K991127 |
| 510k Number | K991127 |
| Device Name: | VARIANT II B-THALASSEMIA |
| Classification | Hemoglobin A2 Quantitation |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | Juliet Carrara |
| Correspondent | Juliet Carrara BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | JPD |
| CFR Regulation Number | 864.7400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-02 |
| Decision Date | 1999-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817012303 | K991127 | 000 |
| 00847817009914 | K991127 | 000 |
| 00847817009204 | K991127 | 000 |
| 00847817008634 | K991127 | 000 |
| 00847817008610 | K991127 | 000 |
| 00847817000805 | K991127 | 000 |
| 00847817000447 | K991127 | 000 |