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 |