EARLY PREGNANCY DETECTION KIT

Visual, Pregnancy Hcg, Prescription Use

RADIOASSAY SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Early Pregnancy Detection Kit.

Pre-market Notification Details

Device IDK781487
510k NumberK781487
Device Name:EARLY PREGNANCY DETECTION KIT
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant RADIOASSAY SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-08-28
Decision Date1978-10-11

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