The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek(r) Hemoglobin A2 Control.
| Device ID | K911347 |
| 510k Number | K911347 |
| Device Name: | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL |
| Classification | Control, Hemoglobin, Abnormal |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | Sharon K Smith |
| Correspondent | Sharon K Smith BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | JCM |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-27 |
| Decision Date | 1991-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002093 | K911347 | 000 |
| 00847661000884 | K911347 | 000 |