(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE

Antisera, Latex Agglutination, Cryptococcus Neoformans

MERIDIAN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for (calas(tm)) W/add'l Reagent Calas(tm) Pronase.

Pre-market Notification Details

Device IDK894845
510k NumberK894845
Device Name:(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
ClassificationAntisera, Latex Agglutination, Cryptococcus Neoformans
Applicant MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
ContactWayne Gade
CorrespondentWayne Gade
MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
Product CodeGMD  
CFR Regulation Number866.3165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-11
Decision Date1989-09-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733101090 K894845 000
00840733101083 K894845 000

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