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FDA 510(k)

BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST

K-Number: K925355 · 1994-07-12

ApplicantPrinceton Biomedix
Decision Date1994-07-12
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Biomedix. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K925355. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST?

BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Princeton Biomedix. The 510(k) number is K925355.

When did BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST receive FDA 510(k) clearance?

BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST received FDA 510(k) clearance on 1994-07-12, under 510(k) number K925355.

Who is the listed applicant for BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST?

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

What is the FDA product code for BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST?

The FDA product code for BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST is LFX.

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Other records listing Princeton Biomedix 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.

K942052LIFESIGN MI MYOGLOBINK930185OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEPK925183BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TESTK926308LIFESIGN HCG - ONE STEP HOME PREGNANCY TESTK901011BIOSIGN HCG-ONE STEP PREGNANCY TESTK894705BIOSPOT HCG-RAPID PREGNANCY TEST

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Related Devices (Code: LFX)

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.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche Diagnostics

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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