The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Ck/ld Isoenzyme Control; Levels 1 And 2.
| Device ID | K903430 |
| 510k Number | K903430 |
| Device Name: | LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 |
| Classification | Enzyme Controls (assayed And Unassayed) |
| 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 | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002154 | K903430 | 000 |
| 00847661001232 | K903430 | 000 |
| 00847661001225 | K903430 | 000 |