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510(k) K032611

Device
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
Applicant
Bio-Rad
510(k) number
K032611
Product code
GGN
Decision
Substantially Equivalent (SESE)
Decision date
2003-09-17
Date received
2003-08-25
Regulation
864.5425
Classification name
Plasma, Coagulation Control
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
MARIA ZEBALLOS
Address
9500 Jeronimo Rd. Irvine CA US 92618 92618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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