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FDA 510(k)

MEASLES-FA LABELLED (8-441 RF)

K-Number: K770805 · 1977-05-20

ApplicantFlow Laboratories, Inc.
Decision Date1977-05-20
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MEASLES-FA LABELLED (8-441 RF) 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 1977-05-20 under 510(k) number K770805. The device is classified under product code GOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEASLES-FA LABELLED (8-441 RF)?

MEASLES-FA LABELLED (8-441 RF) is a medical device that received FDA 510(k) clearance on 1977-05-20. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K770805.

When did MEASLES-FA LABELLED (8-441 RF) receive FDA 510(k) clearance?

MEASLES-FA LABELLED (8-441 RF) received FDA 510(k) clearance on 1977-05-20, under 510(k) number K770805.

Who is the listed applicant for MEASLES-FA LABELLED (8-441 RF)?

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 MEASLES-FA LABELLED (8-441 RF)?

The FDA product code for MEASLES-FA LABELLED (8-441 RF) is GOL.

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Related Devices (Code: GOL)

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.

K841174RUBELLA ANTIBODY FLUOROIMMUNOASSAYIntl. Diagnostic TechnologyK834032RUBAQUICK DIAGNOSTIC KITAbbott LaboratoriesK810309RUBELLA ANTIBODIES TEST REAGENTSCalbiochem-Behring Corp.K802508RUBELISA IGM TEST KITM.A. BioproductsK802102RUBELLA ELISA REAGENTS RUBELLA IGG ANTICalbiochem-Behring Corp.K802339EIA RUBELLA-GBeckman Instruments, 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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