The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Amp Alkaline Phosphatase Reagent Kit.
| Device ID | K931986 |
| 510k Number | K931986 |
| Device Name: | AMP ALKALINE PHOSPHATASE REAGENT KIT |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-22 |
| Decision Date | 1993-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091699 | K931986 | 000 |
| 05060500090111 | K931986 | 000 |
| 05060500090104 | K931986 | 000 |
| 05060500090098 | K931986 | 000 |
| 05060500090081 | K931986 | 000 |
| 05060500090074 | K931986 | 000 |