The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Creatine Kinase Mb Determination (uv).
| Device ID | K942958 |
| 510k Number | K942958 |
| Device Name: | CREATINE KINASE MB DETERMINATION (UV) |
| Classification | U.v. Method, Cpk Isoenzymes |
| Applicant | BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
| Contact | Alejo V Roy, Ph.d. |
| Correspondent | Alejo V Roy, Ph.d. BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
| Product Code | JHW |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-23 |
| Decision Date | 1994-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727010964 | K942958 | 000 |
| 00811727010957 | K942958 | 000 |
| 00811727010940 | K942958 | 000 |
| 00817274021316 | K942958 | 000 |
| 00817274021309 | K942958 | 000 |
| 00817274021293 | K942958 | 000 |
| 00811727018649 | K942958 | 000 |
| 00811727018632 | K942958 | 000 |