The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Isotrak Amylase Test Amylase Isoenzyme.
| Device ID | K853951 |
| 510k Number | K853951 |
| Device Name: | ISOTRAK AMYLASE TEST AMYLASE ISOENZYME |
| Classification | Saccharogenic, Amylase |
| Applicant | BEHRING DIAGNOSTICS, INC. 10933 NO TORREY PINES RD. La Jolla, CA 92037 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 10933 NO TORREY PINES RD. La Jolla, CA 92037 |
| Product Code | CIJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-25 |
| Decision Date | 1986-01-07 |