The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Bacton Tm, Basic Tm, Apo B Reagent.
| Device ID | K893884 |
| 510k Number | K893884 |
| Device Name: | BACTON TM, BASIC TM, APO B REAGENT |
| Classification | Apolipoproteins |
| Applicant | CATACHEM, INC. 955 CONNECTICUT AVENUE Bridgeport, CT 06606 -0216 |
| Contact | George Liggins |
| Correspondent | George Liggins CATACHEM, INC. 955 CONNECTICUT AVENUE Bridgeport, CT 06606 -0216 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-30 |
| Decision Date | 1989-06-21 |