NEIN ALLERGEN DISC IN VAST VENTREX TEST

System, Test, Radioallergosorbent (rast) Immunological

VENTREX LABORATORIES, INC.

The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Nein Allergen Disc In Vast Ventrex Test.

Pre-market Notification Details

Device IDK831554
510k NumberK831554
Device Name:NEIN ALLERGEN DISC IN VAST VENTREX TEST
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-13
Decision Date1983-06-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879022025 K831554 000
00816879022001 K831554 000
00816879021950 K831554 000
00816879021790 K831554 000
00816879021783 K831554 000
00816879021677 K831554 000
00816879021387 K831554 000
00816879021332 K831554 000
00816879021318 K831554 000

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