ROSCO PYRR

Discs, Strips And Reagents, Microorganism Differentiation

PRO-LAB, INC.

The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Rosco Pyrr.

Pre-market Notification Details

Device IDK894221
510k NumberK894221
Device Name:ROSCO PYRR
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant PRO-LAB, INC. P.O. BOX 503 Round Rock,  TX  78664
ContactKay Baitz
CorrespondentKay Baitz
PRO-LAB, INC. P.O. BOX 503 Round Rock,  TX  78664
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-19
Decision Date1989-09-28

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