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 |