TANDEM PAP KIT - (PARTS I & II)— 510(k) K811959

Name: FDA 510(k) clearance K811959
Creator: U.S. Food and Drug Administration
Published: 1981-09-01

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K811959 for TANDEM PAP KIT - (PARTS I & II), Substantially Equivalent on 1981-09-01. Applicant: Hybritech, Inc.. Device class: 2.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1981-07-09
Decision date: 1981-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K922754 — TANDEM-E IGE II CALIBRATION VERIFICATION SET1993-02-17
K921745 — HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO1992-07-30

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