Cleared Traditional

TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET

K920556 · Hybritech, Inc. · Chemistry
Jul 1992
Decision
162d
Days
Class 1
Risk

About This 510(k) Submission

K920556 is an FDA 510(k) clearance for the TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 17, 1992, 162 days after receiving the submission on February 6, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K920556 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1992
Decision Date July 17, 1992
Days to Decision 162 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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