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FDA 510(k)

RUBELLA HEMAGGLUTINATION REAGENT KIT

K-Number: K771957 · 1977-10-28

ApplicantFlow Laboratories, Inc.
Decision Date1977-10-28
Product CodeGOK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA HEMAGGLUTINATION REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1977-10-28 under 510(k) number K771957. The device is classified under product code GOK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBELLA HEMAGGLUTINATION REAGENT KIT?

RUBELLA HEMAGGLUTINATION REAGENT KIT is a medical device that received FDA 510(k) clearance on 1977-10-28. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K771957.

When did RUBELLA HEMAGGLUTINATION REAGENT KIT receive FDA 510(k) clearance?

RUBELLA HEMAGGLUTINATION REAGENT KIT received FDA 510(k) clearance on 1977-10-28, under 510(k) number K771957.

Who is the listed applicant for RUBELLA HEMAGGLUTINATION REAGENT KIT?

The FDA 510(k) record lists Flow Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBELLA HEMAGGLUTINATION REAGENT KIT?

The FDA product code for RUBELLA HEMAGGLUTINATION REAGENT KIT is GOK.

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Other records listing Flow Laboratories, Inc. as applicant

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Related Devices (Code: GOK)

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.

K832228RUBASCAN LATEX CARD TESTBd Becton Dickinson Vacutainer Systems PreanalyticK810835RUBAZYME - MAbbott LaboratoriesK792635ANTIBODY TO RUBELLA VIRUSElectro-Nucleonics Laboratories, Inc.K792133RUBELISA TEST KITMicrobiological Assoc.K790122RUBANONOrganon, Inc.K781638RUBINDEX*DIRECT SYSTEMOrtho Diagnostics, 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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