Cleared Traditional

PREGNANCY-SKREEN

K050328 · Biochemical Diagnostic, Inc. · Chemistry
Mar 2005
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K050328 is an FDA 510(k) clearance for the PREGNANCY-SKREEN, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Biochemical Diagnostic, Inc. (Edgewood, US). The FDA issued a Cleared decision on March 29, 2005, 48 days after receiving the submission on February 9, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K050328 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2005
Decision Date March 29, 2005
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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