Cleared Traditional

PREGNA-CERT, SLIDE PREGNANCY TEST

K831180 · Diagnostic Specialties · Chemistry
May 1983
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K831180 is an FDA 510(k) clearance for the PREGNA-CERT, SLIDE PREGNANCY TEST, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Diagnostic Specialties (Mchenry, US). The FDA issued a Cleared decision on May 27, 1983, 46 days after receiving the submission on April 11, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K831180 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1983
Decision Date May 27, 1983
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHJ — Agglutination Method, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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