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FDA 510(k)

LYFO-KWIK (TM) COAGULASE PLASMA

K-Number: K861312 · 1986-04-18

ApplicantMicro-Bio-Logics
Decision Date1986-04-18
Product CodeJTL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LYFO-KWIK (TM) COAGULASE PLASMA 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 1986-04-18 under 510(k) number K861312. The device is classified under product code JTL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYFO-KWIK (TM) COAGULASE PLASMA?

LYFO-KWIK (TM) COAGULASE PLASMA is a medical device that received FDA 510(k) clearance on 1986-04-18. The listed applicant is Micro-Bio-Logics. The 510(k) number is K861312.

When did LYFO-KWIK (TM) COAGULASE PLASMA receive FDA 510(k) clearance?

LYFO-KWIK (TM) COAGULASE PLASMA received FDA 510(k) clearance on 1986-04-18, under 510(k) number K861312.

Who is the listed applicant for LYFO-KWIK (TM) COAGULASE PLASMA?

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 (TM) COAGULASE PLASMA?

The FDA product code for LYFO-KWIK (TM) COAGULASE PLASMA is JTL.

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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 KITK861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSK855172KWI (TM) G-CO/TWOK855198INDI KWIK (TM) CO/TWO KITK852998NEISSERIA - KWIK PLUSK851978LYFO-KWIK OMI KIT

View all 9 devices →

Related Devices (Code: JTL)

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.

K950706DRYSLIDE COAGULASEDifco Laboratories, Inc.K883333RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENTImmuno-Mycologics, Inc.K870945RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122Oxoid U.S.A., Inc.K840553HEMASTAPHRemel Co.K833988API STAPHASE IIIAnalytical Products, Inc.K833858COAGULASE PLASMA, HORSE & RABBIT EDTAOtisville Biotech, 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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