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510(k) K946265

Device
FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
Applicant
CLINICAL CONTROLS, INC.
510(k) number
K946265
Product code
GIL  
Decision
Substantially Equivalent (SESE)
Decision date
1995-08-24
Date received
1994-12-23
Regulation
864.7340
Classification name
Plasma, Fibrinogen Control
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JAMES F GODFREY
Address
750 Farroll Rd. Suite B Grover Beach CA US 93433 93433

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GIL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962407N/T PROTEIN CONTROL PYBehring Diagnostics, Inc.1996-07-29
K946193FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3More Diagnostics1995-08-24
K935598PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2Clinical Controls, Inc.1995-05-02
K951012N/T PROTEIN CONTROL PYBehring Diagnostics, Inc.1995-04-17
K934741LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2Clinical Controls, Inc.1994-09-08
K915462FIBRINOGEN CONTROLSigma Diagnostics, Inc.1992-03-04
K833352GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROLWarner-Lambert Co.1983-11-03

Legacy Summary#

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FDA Review#

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