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510(k) K951639

Device
COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
Applicant
INCSTAR CORP.
510(k) number
K951639
Product code
DAE  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-13
Date received
1995-04-10
Regulation
866.5240
Classification name
Complement C9, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARY E BEST
Address
1990 Insustrial Blvd. P.O. Box 285 Stillwater MN US 55082 55082

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DAE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150412Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 CalibratorThe Binding Site Group , Ltd.2015-08-28
K113349HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FOThe Binding Site Group , Ltd.2012-07-11
K992488TOTAL HAEMOLYTIC COMPLEMENT RID KITThe Binding Site, Ltd.1999-09-17
K974111QUIDEL CH50 EQ EIAQuidel Corp.1998-07-29
K954145WAKO AUTOKIT CH50Wako Chemicals USA, Inc.1995-12-18

Legacy Summary#

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FDA Review#

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