The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Alkaline Phosphatase Procedure.
Device ID | K861667 |
510k Number | K861667 |
Device Name: | ALKALINE PHOSPHATASE PROCEDURE |
Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
Applicant | DATA MEDICAL ASSOCIATES, INC. 2016 E. RANDOL MILL RD. Arlington, TX 70611 |
Contact | Jerry A Graham |
Correspondent | Jerry A Graham DATA MEDICAL ASSOCIATES, INC. 2016 E. RANDOL MILL RD. Arlington, TX 70611 |
Product Code | CJE |
CFR Regulation Number | 862.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-30 |
Decision Date | 1986-05-29 |