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FDA 510(k)

RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL

K-Number: K803133 · 1981-01-29

ApplicantMicrobiological Research Corp.
Decision Date1981-01-29
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Research Corp.. It received FDA 510(k) clearance on 1981-01-29 under 510(k) number K803133. 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 RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL?

RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL is a medical device that received FDA 510(k) clearance on 1981-01-29. The listed applicant is Microbiological Research Corp.. The 510(k) number is K803133.

When did RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL receive FDA 510(k) clearance?

RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL received FDA 510(k) clearance on 1981-01-29, under 510(k) number K803133.

Who is the listed applicant for RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL?

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

What is the FDA product code for RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL?

The FDA product code for RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL is LFX.

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Other records listing Microbiological Research Corp. 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.

K883011MRI NEO-TRYP TRYPSIN RIAK861120THE GOLDEN QUAD TEST (HSV)K861122THE GOLDEN QUAD TEST (TOXO)K861123THE GOLDEN QUAD TEST (CMV)K861121THE GOLDEN QUAD TEST (EBV)K860450THE CMV-IGM 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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