The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Amylase For Manual/automated Applications.
| Device ID | K902326 |
| 510k Number | K902326 |
| Device Name: | AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS |
| Classification | Catalytic Methods, Amylase |
| Applicant | CATACHEM, INC. P.O. BOX 6216 70 HAWLEY AVENUE Bridgeport, CT 06606 -0216 |
| Contact | Luis P Leon |
| Correspondent | Luis P Leon CATACHEM, INC. P.O. BOX 6216 70 HAWLEY AVENUE Bridgeport, CT 06606 -0216 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-24 |
| Decision Date | 1990-07-31 |