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FDA 510(k)

ONO/CO-TWO (TM) SYSTEMS

K-Number: K844014 · 1984-10-31

ApplicantMicro-Bio-Logics
Decision Date1984-10-31
Product CodeJTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ONO/CO-TWO (TM) SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Bio-Logics. It received FDA 510(k) clearance on 1984-10-31 under 510(k) number K844014. The device is classified under product code JTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONO/CO-TWO (TM) SYSTEMS?

ONO/CO-TWO (TM) SYSTEMS is a medical device that received FDA 510(k) clearance on 1984-10-31. The listed applicant is Micro-Bio-Logics. The 510(k) number is K844014.

When did ONO/CO-TWO (TM) SYSTEMS receive FDA 510(k) clearance?

ONO/CO-TWO (TM) SYSTEMS received FDA 510(k) clearance on 1984-10-31, under 510(k) number K844014.

Who is the listed applicant for ONO/CO-TWO (TM) SYSTEMS?

The FDA 510(k) record lists Micro-Bio-Logics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONO/CO-TWO (TM) SYSTEMS?

The FDA product code for ONO/CO-TWO (TM) SYSTEMS is JTY.

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Other records listing Micro-Bio-Logics 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.

K870731LYFO KWIK(TM) RUS KITK861312LYFO-KWIK (TM) COAGULASE PLASMAK861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSK855172KWI (TM) G-CO/TWOK855198INDI KWIK (TM) CO/TWO KITK852998NEISSERIA - KWIK PLUS

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Related Devices (Code: JTY)

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.

K210511InTray GCBiomed Diagnostics IncorporatedK993033INTRAY GCBiomed Diagnostics, Inc.K954986GC BASE W/ 1% GCHIRemel, L.P.K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIABioclinical Systems, Inc.K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARBioclinical Systems, Inc.K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARBioclinical Systems, 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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