The following data is part of a premarket notification filed by Clinical Controls, Inc. with the FDA for Cardiospex(tm) Ckmb/ld-1 Immunoinhibition Control.
| Device ID | K946145 |
| 510k Number | K946145 |
| Device Name: | CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL |
| 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 | 1994-12-16 |
| Decision Date | 1995-01-24 |