The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Glucose Hk Procedure.
Device ID | K861653 |
510k Number | K861653 |
Device Name: | GLUCOSE HK PROCEDURE |
Classification | Glucose Oxidase, Glucose |
Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Contact | Jerry A Graham |
Correspondent | Jerry A Graham DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-30 |
Decision Date | 1986-05-23 |