ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE

Visual, Pregnancy Hcg, Prescription Use

CENOGENICS CORP.

The following data is part of a premarket notification filed by Cenogenics Corp. with the FDA for Accunate-one Step, Accunate-one Step Cassette.

Pre-market Notification Details

Device IDK992397
510k NumberK992397
Device Name:ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant CENOGENICS CORP. 100 RT. 520 Morganville,  NJ  07751
ContactNitza Katz
CorrespondentNitza Katz
CENOGENICS CORP. 100 RT. 520 Morganville,  NJ  07751
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-19
Decision Date1999-08-26
Summary:summary

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