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510(k) K853803

Device
Fetal Bovine/fetal Calf Serum, Newborn, Horse, Rab
Applicant
Z.L. BOCKNEK LABORATORIES, INC.
510(k) number
K853803
Product code
KIS
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-15
Date received
1985-09-11
Regulation
864.2800
Classification name
Sera, Animal And Human
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL HAFFENDEN
Address
165 Bethridge Rd. Rexdale, Toronto Ontario Canada Maw In1 CA

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KIS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881287ANIMAL AND HUMAN SERACell Culture Laboratories1988-04-05
K880471BOVINE CALF SERUM SUPPLEMENTED #A-2159Hyclone Laboratories, Inc.1988-04-04
K880470BOVINE CALF SERUM CATALOG #A-2119Hyclone Laboratories, Inc.1988-04-01
K872847SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENTCandace Lane Corp.1987-08-10
K870580MLC NORMAL SERUMRjo Biologicals, Inc.1987-04-08
K870938FETAL BOVINE SERUMHyclone Laboratories, Inc.1987-03-31
K8704656/40 FETAL BOVINE SERUM #A-1110Hyclone Laboratories, Inc.1987-03-24
K870463DEFINED FETAL BOVINE SERUM #A-1111Hyclone Laboratories, Inc.1987-03-24
K870464CHARACTERIZED FETAL BOVINE SERUM #A-1115Hyclone Laboratories, Inc.1987-03-24
K870466DEFINED CALF BOVINE SERUM #A-2111Hyclone Laboratories, Inc.1987-03-24
K870467DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151Hyclone Laboratories, Inc.1987-03-24
K870468ADULT BOVINE SERUMHyclone Laboratories, Inc.1987-03-24
K870469DEFINED EQUINE SERUM #A-3311Hyclone Laboratories, Inc.1987-03-24
K861817HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATEDHazleton Research Products, Inc.1986-05-20
K861816MOUSE BLOOD CELLS IN ALSEVERS OR CITRATEHazleton Research Products, Inc.1986-05-20