The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Analyzer.
Device ID | K981610 |
510k Number | K981610 |
Device Name: | CARESIDE ANALYZER |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
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 | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-30 |
Decision Date | 1998-06-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARESIDE ANALYZER 75298942 2375634 Dead/Cancelled |
CARESIDE, INC. 1997-05-27 |