Product code KIS

Device name: Sera, Animal And Human
Medical specialty: Hematology
Device class: 1
Regulation number: 864.2800
Review panel: PA
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K881287	ANIMAL AND HUMAN SERA	Cell Culture Laboratories	1988-04-05
K880471	BOVINE CALF SERUM SUPPLEMENTED #A-2159	Hyclone Laboratories, Inc.	1988-04-04
K880470	BOVINE CALF SERUM CATALOG #A-2119	Hyclone Laboratories, Inc.	1988-04-01
K872847	SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT	Candace Lane Corp.	1987-08-10
K870580	MLC NORMAL SERUM	Rjo Biologicals, Inc.	1987-04-08
K870938	FETAL BOVINE SERUM	Hyclone Laboratories, Inc.	1987-03-31
K870465	6/40 FETAL BOVINE SERUM #A-1110	Hyclone Laboratories, Inc.	1987-03-24
K870463	DEFINED FETAL BOVINE SERUM #A-1111	Hyclone Laboratories, Inc.	1987-03-24
K870464	CHARACTERIZED FETAL BOVINE SERUM #A-1115	Hyclone Laboratories, Inc.	1987-03-24
K870466	DEFINED CALF BOVINE SERUM #A-2111	Hyclone Laboratories, Inc.	1987-03-24
K870467	DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151	Hyclone Laboratories, Inc.	1987-03-24
K870468	ADULT BOVINE SERUM	Hyclone Laboratories, Inc.	1987-03-24
K870469	DEFINED EQUINE SERUM #A-3311	Hyclone Laboratories, Inc.	1987-03-24
K861817	HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED	Hazleton Research Products, Inc.	1986-05-20
K861816	MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE	Hazleton Research Products, Inc.	1986-05-20
K861815	BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE	Hazleton Research Products, Inc.	1986-05-20
K861814	RHESUS MONKEY SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20
K861813	HUMAN AB SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20
K861812	HUMAN SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20
K861811	MOUSE SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20
K861810	CHICKEN SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20
K861809	LAMB SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20
K860762	GAMMA-FREE HORSE SERUM	Flow Laboratories, Inc.	1986-03-10
K860752	GOAT SERUM (29-391-54)	Flow Laboratories, Inc.	1986-03-10
K853803	FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB	Z.L. Bocknek Laboratories, Inc.	1985-10-15
K843629	FETAL BOVINE SERUM, F4884 STERILE GROWT	Sigma Chemical Co.	1984-10-01
K833463	CLEX	Dextran Products, Ltd.	1983-11-21
K812380	RABBIT SERUM - STERILE	Dutchland Laboratories, Inc.	1981-09-08
K812379	GUINEA PIG SERUM - STERILE	Dutchland Laboratories, Inc.	1981-09-08
K812381	DONOR HORSE SERUM - STERILE	Dutchland Laboratories, Inc.	1981-09-08

Product code KIS

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