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510(k) K861312

Device
LYFO-KWIK (TM) COAGULASE PLASMA
Applicant
MICRO-BIO-LOGICS
510(k) number
K861312
Product code
JTL  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-18
Date received
1986-04-08
Regulation
866.2160
Classification name
Plasma, Coagulase, Human, Horse And Rabbit
Medical specialty
Microbiology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GERALD TJERNAGEL
Address
217 Osseo Ave. N. St. Cloud MN US 56301 56301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JTL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950706DRYSLIDE COAGULASEDifco Laboratories, Inc.1995-05-16
K883333RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENTImmuno-Mycologics, Inc.1988-08-25
K870945RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122Oxoid U.S.A., Inc.1987-06-10
K840553HEMASTAPHRemel Co.1984-04-13
K833988API STAPHASE IIIAnalytical Products, Inc.1983-12-22
K833858COAGULASE PLASMA, HORSE & RABBIT EDTAOtisville Biotech, Inc.1983-12-08
K822988COAGULASE PLASMA-CITRATED & EDTAAmerican Scientific Products1982-11-05
K820177COAGULASE PLASMAQuadroma, Inc.1982-02-05
K812602RABBIT COAGULASE PLASMADutchland Laboratories, Inc.1981-09-29
K811982STAPHASE*Analytical Products, Inc.1981-07-28
K792235COAGULASE PLASMARemel Co.1979-12-07

Legacy Summary#

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FDA Review#

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