The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Lactate Dehydrogenase (ld) Procedure.
Device ID | K861662 |
510k Number | K861662 |
Device Name: | LACTATE DEHYDROGENASE (LD) PROCEDURE |
Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
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 | CFJ |
CFR Regulation Number | 862.1440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-30 |
Decision Date | 1986-05-29 |