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FDA 510(k)

LYFO-KWIK OMI KIT

K-Number: K851978 · 1985-06-04

ApplicantMicro-Bio-Logics
Decision Date1985-06-04
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LYFO-KWIK OMI 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 1985-06-04 under 510(k) number K851978. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYFO-KWIK OMI KIT?

LYFO-KWIK OMI KIT is a medical device that received FDA 510(k) clearance on 1985-06-04. The listed applicant is Micro-Bio-Logics. The 510(k) number is K851978.

When did LYFO-KWIK OMI KIT receive FDA 510(k) clearance?

LYFO-KWIK OMI KIT received FDA 510(k) clearance on 1985-06-04, under 510(k) number K851978.

Who is the listed applicant for LYFO-KWIK OMI 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 LYFO-KWIK OMI KIT?

The FDA product code for LYFO-KWIK OMI KIT is JSS.

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: JSS)

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.

K123418GRAM-NEGATIVE QUICKFISH BCAdvandx, Inc.K101558GNR TRAFFIC LIGHT PNA FISHAdvandx, Inc.K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc.K092393EK/P. AERUGINOSA PNA FISHAdvandx, Inc.K082068E. COLI PNA FISHAdvandx, Inc.K081433EK/P. AERUGINOSA PNA FISHAdvandx, 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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