HCG ACCU-STICK

Visual, Pregnancy Hcg, Prescription Use

BTC DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Btc Diagnostics, Inc. with the FDA for Hcg Accu-stick.

Pre-market Notification Details

Device IDK831604
510k NumberK831604
Device Name:HCG ACCU-STICK
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant BTC DIAGNOSTICS, 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 Received1983-05-18
Decision Date1983-07-19

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