The following data is part of a premarket notification filed by Cala Diagnostics with the FDA for Cardiochex.
| Device ID | K944243 |
| 510k Number | K944243 |
| Device Name: | CARDIOCHEX |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | CALA DIAGNOSTICS 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey CALA DIAGNOSTICS 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 | 1994-08-31 |
| Decision Date | 1994-10-27 |