The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Creatine Kinase (ck).
| Device ID | K972155 |
| 510k Number | K972155 |
| Device Name: | CREATINE KINASE (CK) |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | Kirk Johnson |
| Correspondent | Kirk Johnson STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-05 |
| Decision Date | 1997-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015006 | K972155 | 000 |
| 00811727010919 | K972155 | 000 |
| 00811727010926 | K972155 | 000 |
| 00811727010933 | K972155 | 000 |
| 00811727012661 | K972155 | 000 |
| 00811727012999 | K972155 | 000 |
| 00811727013477 | K972155 | 000 |
| 00811727014030 | K972155 | 000 |
| 00811727014047 | K972155 | 000 |
| 00811727014696 | K972155 | 000 |
| 00811727016096 | K972155 | 000 |