The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Mg.
Device ID | K991717 |
510k Number | K991717 |
Device Name: | CARESIDE MG |
Classification | Photometric Method, Magnesium |
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 | JGJ |
CFR Regulation Number | 862.1495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-20 |
Decision Date | 1999-08-10 |
Summary: | summary |