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FDA 510(k)

FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES

K-Number: K844346 · 1985-03-04

ApplicantFisher Diagnostics
Decision Date1985-03-04
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Diagnostics. It received FDA 510(k) clearance on 1985-03-04 under 510(k) number K844346. 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 FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES?

FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES is a medical device that received FDA 510(k) clearance on 1985-03-04. The listed applicant is Fisher Diagnostics. The 510(k) number is K844346.

When did FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES receive FDA 510(k) clearance?

FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES received FDA 510(k) clearance on 1985-03-04, under 510(k) number K844346.

Who is the listed applicant for FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES?

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

What is the FDA product code for FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES?

The FDA product code for FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES is JHJ.

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Other records listing Fisher Diagnostics 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.

K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsK070640ARCHITECT STAT TROPONIN-1; MYOGLOBINK052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSK052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMK042924ARCHITECT STAT MYO IMMUNOASSAYK041192ARCHITECT STAT TROPONIN-I IMMUNOASSAY

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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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