The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Alp (alkaline Phosphatase) Reagent.
Device ID | K860715 |
510k Number | K860715 |
Device Name: | ALP (ALKALINE PHOSPHATASE) REAGENT |
Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
Contact | Riddle |
Correspondent | Riddle TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
Product Code | CJE |
CFR Regulation Number | 862.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-26 |
Decision Date | 1986-04-24 |