The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Lactate Dehydrogenase Isoenzyme 1.
Device ID | K872891 |
510k Number | K872891 |
Device Name: | LACTATE DEHYDROGENASE ISOENZYME 1 |
Classification | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes |
Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Contact | Marjorie B Potts |
Correspondent | Marjorie B Potts DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Product Code | CEX |
CFR Regulation Number | 862.1445 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-23 |
Decision Date | 1987-09-16 |