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FDA 510(k)

HCG-NOSTICK

K-Number: K880328 · 1988-03-15

ApplicantOrganon Teknika Corp.
Decision Date1988-03-15
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCG-NOSTICK is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1988-03-15 under 510(k) number K880328. 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 HCG-NOSTICK?

HCG-NOSTICK is a medical device that received FDA 510(k) clearance on 1988-03-15. The listed applicant is Organon Teknika Corp.. The 510(k) number is K880328.

When did HCG-NOSTICK receive FDA 510(k) clearance?

HCG-NOSTICK received FDA 510(k) clearance on 1988-03-15, under 510(k) number K880328.

Who is the listed applicant for HCG-NOSTICK?

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

What is the FDA product code for HCG-NOSTICK?

The FDA product code for HCG-NOSTICK is JHJ.

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Other records listing Organon Teknika Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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Related Devices (Code: JHJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

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