PORPHYRIN (ALA) DISK

Discs, Strips And Reagents, Microorganism Differentiation

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Porphyrin (ala) Disk.

Pre-market Notification Details

Device IDK801492
510k NumberK801492
Device Name:PORPHYRIN (ALA) DISK
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant REMEL CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-06-26
Decision Date1980-08-13

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