The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Ultraviolet Lactate Dehydrogenase Reagent Set.
Device ID | K871781 |
510k Number | K871781 |
Device Name: | ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET |
Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
Applicant | BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami, FL 33152 |
Contact | Roy, Ph.d. |
Correspondent | Roy, Ph.d. BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami, FL 33152 |
Product Code | CFJ |
CFR Regulation Number | 862.1440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-06 |
Decision Date | 1987-06-03 |