The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Amylase Test Item 97381/94 (r1, 97382/94 (r2-sr).
| Device ID | K951494 |
| 510k Number | K951494 |
| Device Name: | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) |
| Classification | Saccharogenic, Amylase |
| Applicant | EMD CHEMICALS INC. 480 SOUTH DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner EMD CHEMICALS INC. 480 SOUTH DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CIJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-31 |
| Decision Date | 1995-12-11 |