Cleared Traditional

TANDEM-E IGE II CALIBRATION VERIFICATION SET

K922754 · Hybritech, Inc. · Immunology
Feb 1993
Decision
254d
Days
Class 1
Risk

About This 510(k) Submission

K922754 is an FDA 510(k) clearance for the TANDEM-E IGE II CALIBRATION VERIFICATION 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 February 17, 1993, 254 days after receiving the submission on June 8, 1992. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K922754 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1992
Decision Date February 17, 1993
Days to Decision 254 days
Submission Type Traditional
Review Panel Immunology (IM)
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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