Cleared Traditional

TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

K921252 · Hybritech, Inc. · Chemistry
Jul 1992
Decision
123d
Days
Class 1
Risk

About This 510(k) Submission

K921252 is an FDA 510(k) clearance for the TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL, 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, 123 days after receiving the submission on March 16, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K921252 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1992
Decision Date July 17, 1992
Days to Decision 123 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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