The following data is part of a premarket notification filed by Cala Diagnostics with the FDA for Cardiochex Ckmb Mass Measurement Control.
Device ID | K944246 |
510k Number | K944246 |
Device Name: | CARDIOCHEX CKMB MASS MEASUREMENT CONTROL |
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 | 1994-10-31 |