MODIFIED IDS RAPID NH SYSTEM

Kit, Identification, Neisseria Gonorrhoeae

INNOVATIVE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Innovative Diagnostic Systems, Inc. with the FDA for Modified Ids Rapid Nh System.

Pre-market Notification Details

Device IDK881501
510k NumberK881501
Device Name:MODIFIED IDS RAPID NH SYSTEM
ClassificationKit, Identification, Neisseria Gonorrhoeae
Applicant INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta,  GA  30340
ContactLouis A Eriquez,phd
CorrespondentLouis A Eriquez,phd
INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta,  GA  30340
Product CodeJSX  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-11
Decision Date1988-05-18

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