The following data is part of a premarket notification filed by Cala Diagnostics with the FDA for Ckmb Isoenzyme Control-level 1,2.3.
Device ID | K930873 |
510k Number | K930873 |
Device Name: | CKMB ISOENZYME CONTROL-LEVEL 1,2.3 |
Classification | Enzyme Controls (assayed And Unassayed) |
Applicant | CALA DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
Contact | James F Godfrey |
Correspondent | James F Godfrey CALA DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
Product Code | JJT |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-19 |
Decision Date | 1993-04-13 |