The following data is part of a premarket notification filed by Tech Intl. Co. with the FDA for Creatine Kinase-mb (ck-mb) Reagent Set.
| Device ID | K915709 |
| 510k Number | K915709 |
| Device Name: | CREATINE KINASE-MB (CK-MB) REAGENT SET |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | TECH INTL. CO. 1856 STARR-BATT DR. Rochester Hills, MI 48309 |
| Contact | Chen |
| Correspondent | Chen TECH INTL. CO. 1856 STARR-BATT DR. Rochester Hills, MI 48309 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001655 | K915709 | 000 |
| 10673486001648 | K915709 | 000 |