FASTPACK HCG IMMUNOASSAY

Visual, Pregnancy Hcg, Prescription Use

Qualigen, Inc.

The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Hcg Immunoassay.

Pre-market Notification Details

Device IDK072264
510k NumberK072264
Device Name:FASTPACK HCG IMMUNOASSAY
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad,  CA  92011
ContactMichael S Poirier
CorrespondentMichael S Poirier
Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad,  CA  92011
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-15
Decision Date2007-12-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816467020112 K072264 000
00816467020105 K072264 000
10816467020126 K072264 000

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