The following data is part of a premarket notification filed by Worthington Biochemical Corp. with the FDA for Ldh Isoenzyme Column Reagent Set.
Device ID | K772356 |
510k Number | K772356 |
Device Name: | LDH ISOENZYME COLUMN REAGENT SET |
Classification | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes |
Applicant | WORTHINGTON BIOCHEMICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CEX |
CFR Regulation Number | 862.1445 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-27 |
Decision Date | 1978-01-24 |