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FDA 510(k)

FERTITELL DIRECT PREGNANCY TEST #1100

K-Number: K832557 · 1983-09-12

ApplicantStanbio Laboratory
Decision Date1983-09-12
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FERTITELL DIRECT PREGNANCY TEST #1100 is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832557. 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 FERTITELL DIRECT PREGNANCY TEST #1100?

FERTITELL DIRECT PREGNANCY TEST #1100 is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Stanbio Laboratory. The 510(k) number is K832557.

When did FERTITELL DIRECT PREGNANCY TEST #1100 receive FDA 510(k) clearance?

FERTITELL DIRECT PREGNANCY TEST #1100 received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832557.

Who is the listed applicant for FERTITELL DIRECT PREGNANCY TEST #1100?

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

What is the FDA product code for FERTITELL DIRECT PREGNANCY TEST #1100?

The FDA product code for FERTITELL DIRECT PREGNANCY TEST #1100 is JHJ.

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Other records listing Stanbio Laboratory as applicant

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K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK050283CREATININE LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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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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