NEIS NZY

Discs, Strips And Reagents, Microorganism Differentiation

CARR-SCARBOROUGH MICROBIOLOGICALS, INC.

The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Neis Nzy.

Pre-market Notification Details

Device IDK863216
510k NumberK863216
Device Name:NEIS NZY
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P.O. BOX 1328 Stone Mountain,  GA  30086
ContactScarborough, Jr
CorrespondentScarborough, Jr
CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P.O. BOX 1328 Stone Mountain,  GA  30086
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-20
Decision Date1986-09-15

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