LDH ISOENZYME CONTROL SERUM

Multi-analyte Controls, All Kinds (assayed)

WORTHINGTON BIOCHEMICAL CORP.

The following data is part of a premarket notification filed by Worthington Biochemical Corp. with the FDA for Ldh Isoenzyme Control Serum.

Pre-market Notification Details

Device IDK780096
510k NumberK780096
Device Name:LDH ISOENZYME CONTROL SERUM
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant WORTHINGTON BIOCHEMICAL CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-01-18
Decision Date1978-03-03

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