The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Ggt.
Device ID | K020486 |
510k Number | K020486 |
Device Name: | CARESIDE GGT |
Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
Applicant | CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
Contact | Kenneth B Asarch |
Correspondent | Kenneth B Asarch CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
Product Code | JPZ |
CFR Regulation Number | 862.1360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-13 |
Decision Date | 2002-07-01 |
Summary: | summary |