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FDA 510(k)

B-SLIDE PREGNATE PREGNANCY TEST KIT

K-Number: K832879 · 1983-10-28

ApplicantFisher Scientific Co., LLC
Decision Date1983-10-28
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

B-SLIDE PREGNATE PREGNANCY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1983-10-28 under 510(k) number K832879. 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 B-SLIDE PREGNATE PREGNANCY TEST KIT?

B-SLIDE PREGNATE PREGNANCY TEST KIT is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K832879.

When did B-SLIDE PREGNATE PREGNANCY TEST KIT receive FDA 510(k) clearance?

B-SLIDE PREGNATE PREGNANCY TEST KIT received FDA 510(k) clearance on 1983-10-28, under 510(k) number K832879.

Who is the listed applicant for B-SLIDE PREGNATE PREGNANCY TEST KIT?

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

What is the FDA product code for B-SLIDE PREGNATE PREGNANCY TEST KIT?

The FDA product code for B-SLIDE PREGNATE PREGNANCY TEST KIT is JHJ.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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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