The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Creatine Kinase (ck) Reagent Set.
| Device ID | K881237 |
| 510k Number | K881237 |
| Device Name: | CREATINE KINASE (CK) REAGENT SET |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | TECH-NEAL SCIENTIFIC, INC. 5410 S. KILPATRICK AVE. Chicago, IL 60632 |
| Contact | Arun Sanghavi |
| Correspondent | Arun Sanghavi TECH-NEAL SCIENTIFIC, INC. 5410 S. KILPATRICK AVE. Chicago, IL 60632 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-04-28 |