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FDA 510(k)

PREGNOSPIA II

K-Number: K881435 · 1988-05-27

ApplicantOrganon Teknika Corp.
Decision Date1988-05-27
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNOSPIA II 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 1988-05-27 under 510(k) number K881435. 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 PREGNOSPIA II?

PREGNOSPIA II is a medical device that received FDA 510(k) clearance on 1988-05-27. The listed applicant is Organon Teknika Corp.. The 510(k) number is K881435.

When did PREGNOSPIA II receive FDA 510(k) clearance?

PREGNOSPIA II received FDA 510(k) clearance on 1988-05-27, under 510(k) number K881435.

Who is the listed applicant for PREGNOSPIA II?

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 PREGNOSPIA II?

The FDA product code for PREGNOSPIA II is JHJ.

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Other records listing Organon Teknika Corp. as applicant

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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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