The following data is part of a premarket notification filed by Worthington Biochemical Corp. with the FDA for Ldh Isoenzyme Control Serum.
Device ID | K780096 |
510k Number | K780096 |
Device Name: | LDH ISOENZYME CONTROL SERUM |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | WORTHINGTON BIOCHEMICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-01-18 |
Decision Date | 1978-03-03 |