The following data is part of a premarket notification filed by Intl. Bioclinical, Inc. with the FDA for Abc Fp Analyzer.
Device ID | K883533 |
510k Number | K883533 |
Device Name: | ABC FP ANALYZER |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | INTL. BIOCLINICAL, INC. DBA AMERICAN BIOCLINICAL 4432 S.E. 16TH AVENUE Portland, OR 97202 |
Contact | Janelle M Batley |
Correspondent | Janelle M Batley INTL. BIOCLINICAL, INC. DBA AMERICAN BIOCLINICAL 4432 S.E. 16TH AVENUE Portland, OR 97202 |
Product Code | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-18 |
Decision Date | 1988-12-15 |