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FDA 510(k)

PREGNA-CERT, SLIDE PREGNANCY TEST

K-Number: K831180 · 1983-05-27

ApplicantDiagnostic Specialties
Decision Date1983-05-27
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNA-CERT, SLIDE PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Specialties. It received FDA 510(k) clearance on 1983-05-27 under 510(k) number K831180. 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 PREGNA-CERT, SLIDE PREGNANCY TEST?

PREGNA-CERT, SLIDE PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1983-05-27. The listed applicant is Diagnostic Specialties. The 510(k) number is K831180.

When did PREGNA-CERT, SLIDE PREGNANCY TEST receive FDA 510(k) clearance?

PREGNA-CERT, SLIDE PREGNANCY TEST received FDA 510(k) clearance on 1983-05-27, under 510(k) number K831180.

Who is the listed applicant for PREGNA-CERT, SLIDE PREGNANCY TEST?

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

What is the FDA product code for PREGNA-CERT, SLIDE PREGNANCY TEST?

The FDA product code for PREGNA-CERT, SLIDE PREGNANCY TEST is JHJ.

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Other records listing Diagnostic Specialties 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.

K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITK941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITK930823PROTEIN-BOUND GLUCOSE ASSAYN KITK922032ENZIP URINARY MICROALBUMIN TESTK823109GENERIC PREGNANCY TESTK813608POTASSIUM REAGENT SET

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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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