The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Amylase Test Kit.
| Device ID | K872023 |
| 510k Number | K872023 |
| Device Name: | AMYLASE TEST KIT |
| Classification | Catalytic Methods, Amylase |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. GILFORD SYSTEMS 132 ARTINO STREET Oberlin, OH 44074 |
| Contact | Craig H Reason |
| Correspondent | Craig H Reason CIBA CORNING DIAGNOSTICS CORP. GILFORD SYSTEMS 132 ARTINO STREET Oberlin, OH 44074 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-26 |
| Decision Date | 1987-08-05 |