FDA 510(k)

QUIDEL HCG ENZYME IMMUNOASSAY KIT

K-Number: K833156 · 1983-11-25

Decision Date1983-11-25

Product CodeJHJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

QUIDEL HCG ENZYME IMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1983-11-25 under 510(k) number K833156. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIDEL HCG ENZYME IMMUNOASSAY KIT?

QUIDEL HCG ENZYME IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1983-11-25. The listed applicant is Quidel Corp.. The 510(k) number is K833156.

When did QUIDEL HCG ENZYME IMMUNOASSAY KIT receive FDA 510(k) clearance?

QUIDEL HCG ENZYME IMMUNOASSAY KIT received FDA 510(k) clearance on 1983-11-25, under 510(k) number K833156.

Who is the listed applicant for QUIDEL HCG ENZYME IMMUNOASSAY KIT?

The FDA 510(k) record lists Quidel Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUIDEL HCG ENZYME IMMUNOASSAY KIT?

The FDA product code for QUIDEL HCG ENZYME IMMUNOASSAY KIT is JHJ.

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Other records listing Quidel Corp. as applicant

K131813QUIDEL MOLECULAR RSV + HMPV ASSAY K131728QUIDEL MOLECULAR INFLUENZA A + B ASSAY K130398SOFIA(R) RSV FIA K131166SOFIA(R) HCG FIA K131606SOFIA INFLUENZA A+B FIA K131619QUICKVUE INFLUENZA A+B

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Related Devices (Code: JHJ)

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.