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FDA 510(k)

INDI KWIK (TM) CO/TWO KIT

K-Number: K855198 · 1986-01-14

ApplicantMicro-Bio-Logics
Decision Date1986-01-14
Product CodeJTR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDI KWIK (TM) CO/TWO KIT 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 1986-01-14 under 510(k) number K855198. The device is classified under product code JTR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDI KWIK (TM) CO/TWO KIT?

INDI KWIK (TM) CO/TWO KIT is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Micro-Bio-Logics. The 510(k) number is K855198.

When did INDI KWIK (TM) CO/TWO KIT receive FDA 510(k) clearance?

INDI KWIK (TM) CO/TWO KIT received FDA 510(k) clearance on 1986-01-14, under 510(k) number K855198.

Who is the listed applicant for INDI KWIK (TM) CO/TWO KIT?

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 INDI KWIK (TM) CO/TWO KIT?

The FDA product code for INDI KWIK (TM) CO/TWO KIT is JTR.

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/TWOK852998NEISSERIA - KWIK PLUSK851978LYFO-KWIK OMI KIT

View all 9 devices →

Related Devices (Code: JTR)

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.

K871121PROTECT T.M.Pro-Lab, Inc.K862914FEKAL CHECK PARASITOLOGY CONTROL SLIDETrend Scientific, Inc.K861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-LogicsK842579B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONSBiological & Environmental Control LaboratoriesK842129LYFO-DISK MICROORGANISMSMicro-Bio-LogicsK831653LYOPHILIZED MICROORGANISMSAustin Biological Laboratories

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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