The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Catachem, Inc., Bile Acids Reagents And/or Bile Acids Test Kit.
| Device ID | K062503 |
| 510k Number | K062503 |
| Device Name: | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT |
| Classification | Radioimmunoassay, Cholyglycine, Bile Acids |
| Applicant | CATACHEM, INC. 955 CONNECTICUT AVENUE SUITE 4106 Bridgeport, CT 06607 |
| Contact | Luis P Leon |
| Correspondent | Luis P Leon CATACHEM, INC. 955 CONNECTICUT AVENUE SUITE 4106 Bridgeport, CT 06607 |
| Product Code | KWW |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1177 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-25 |
| Decision Date | 2007-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853618007011 | K062503 | 000 |