The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Uibc For Discreet Random Access Analyzer.
| Device ID | K932871 |
| 510k Number | K932871 |
| Device Name: | UIBC FOR DISCREET RANDOM ACCESS ANALYZER |
| Classification | Bathophenanthroline, Colorimetry, Iron (non-heme) |
| Applicant | CATACHEM, INC. 70 HAWLEY AVE. Bridgeport, CT 06606 |
| Contact | Luis Leon |
| Correspondent | Luis Leon CATACHEM, INC. 70 HAWLEY AVE. Bridgeport, CT 06606 |
| Product Code | CFM |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-14 |
| Decision Date | 1993-09-08 |