The following data is part of a premarket notification filed by Clinical Controls, Inc. with the FDA for Ckmb/myoglobin Mass Measuremeny Control Level 1, 2, 3,.
| Device ID | K944923 |
| 510k Number | K944923 |
| Device Name: | CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-06 |
| Decision Date | 1994-11-04 |