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FDA 510(k)

CYTOMEGILISH TEST KIT

K-Number: K781392 · 1978-10-24

ApplicantMicrobiological Assoc.
Decision Date1978-10-24
Product CodeGOK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGILISH TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Assoc.. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781392. 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 CYTOMEGILISH TEST KIT?

CYTOMEGILISH TEST KIT is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is Microbiological Assoc.. The 510(k) number is K781392.

When did CYTOMEGILISH TEST KIT receive FDA 510(k) clearance?

CYTOMEGILISH TEST KIT received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781392.

Who is the listed applicant for CYTOMEGILISH TEST KIT?

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

What is the FDA product code for CYTOMEGILISH TEST KIT?

The FDA product code for CYTOMEGILISH TEST KIT is GOK.

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Other records listing Microbiological Assoc. 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.

K792133RUBELISA TEST KITK791397HERPES EIA TEST KITK781549TOXELISA TEST KITK780996RUBELISA TEST KITK781143IMMUNOFLUORESCENCE TEST KITK770764TISSUE CULTURE MEDIA W/HEPES BUFFER

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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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