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FDA 510(k)

SLIDE PREGNANCY TEST

K-Number: K842110 · 1984-07-12

ApplicantImmunostics Co., Inc.
Decision Date1984-07-12
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SLIDE PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Co., Inc.. It received FDA 510(k) clearance on 1984-07-12 under 510(k) number K842110. 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 SLIDE PREGNANCY TEST?

SLIDE PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1984-07-12. The listed applicant is Immunostics Co., Inc.. The 510(k) number is K842110.

When did SLIDE PREGNANCY TEST receive FDA 510(k) clearance?

SLIDE PREGNANCY TEST received FDA 510(k) clearance on 1984-07-12, under 510(k) number K842110.

Who is the listed applicant for SLIDE PREGNANCY TEST?

The FDA 510(k) record lists Immunostics Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLIDE PREGNANCY TEST?

The FDA product code for SLIDE PREGNANCY TEST is JHJ.

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Other records listing Immunostics Co., Inc. 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.

K926569IMMUNO RA UNDILUTEDK902360HEMA-SCREENK894780IMMUNO/ASOK883685IMMUNO/FEBRILE ANTIGENSK872910IMMUNO/SLEK863741IMMUNO-CEPT D (BETA-MONOCLONAL)

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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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