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 |