Cleared Traditional

GENERIC PREGNANCY TEST

K823109 · Diagnostic Specialties · Chemistry
Nov 1982
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K823109 is an FDA 510(k) clearance for the GENERIC PREGNANCY TEST, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Diagnostic Specialties (Mchenry, US). The FDA issued a Cleared decision on November 10, 1982, 20 days after receiving the submission on October 21, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K823109 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1982
Decision Date November 10, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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