Cleared Traditional

B-HCG HUMAN SERUM CONTROLS

K932479 · Pyramid Biological Corp. · Chemistry
Dec 1993
Decision
192d
Days
Class 1
Risk

About This 510(k) Submission

K932479 is an FDA 510(k) clearance for the B-HCG HUMAN SERUM CONTROLS, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on December 2, 1993, 192 days after receiving the submission on May 24, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K932479 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1993
Decision Date December 02, 1993
Days to Decision 192 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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