KIS · Class I · 21 CFR 864.2800

FDA Product Code KIS: Sera, Animal And Human

Leading manufacturers include Hyclone Laboratories, Inc., Dutchland Laboratories, Inc. and Hazleton Research Products, Inc..

45
Total
45
Cleared
26d
Avg days
1978
Since

FDA 510(k) Cleared Sera, Animal And Human Devices (Product Code KIS)

45 devices
1–24 of 45
Cleared Apr 05, 1988
ANIMAL AND HUMAN SERA
K881287
Cell Culture Laboratories
Pathology · 8d
Cleared Apr 04, 1988
BOVINE CALF SERUM SUPPLEMENTED #A-2159
K880471
Hyclone Laboratories, Inc.
Pathology · 61d
Cleared Apr 01, 1988
BOVINE CALF SERUM CATALOG #A-2119
K880470
Hyclone Laboratories, Inc.
Pathology · 58d
Cleared Aug 10, 1987
SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT
K872847
Candace Lane Corp.
Pathology · 21d
Cleared Apr 08, 1987
MLC NORMAL SERUM
K870580
Rjo Biologicals, Inc.
Pathology · 56d
Cleared Mar 31, 1987
FETAL BOVINE SERUM
K870938
Hyclone Laboratories, Inc.
Pathology · 22d
Cleared Mar 24, 1987
DEFINED FETAL BOVINE SERUM #A-1111
K870463
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
CHARACTERIZED FETAL BOVINE SERUM #A-1115
K870464
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
6/40 FETAL BOVINE SERUM #A-1110
K870465
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
DEFINED CALF BOVINE SERUM #A-2111
K870466
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151
K870467
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
ADULT BOVINE SERUM
K870468
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
DEFINED EQUINE SERUM #A-3311
K870469
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared May 20, 1986
LAMB SERUM - STERILE FILTERED
K861809
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
CHICKEN SERUM - STERILE FILTERED
K861810
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
MOUSE SERUM - STERILE FILTERED
K861811
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
HUMAN SERUM - STERILE FILTERED
K861812
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
HUMAN AB SERUM - STERILE FILTERED
K861813
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
RHESUS MONKEY SERUM - STERILE FILTERED
K861814
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE
K861815
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE
K861816
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED
K861817
Hazleton Research Products, Inc.
Pathology · 11d
Cleared Mar 10, 1986
GOAT SERUM (29-391-54)
K860752
Flow Laboratories, Inc.
Pathology · 10d
Cleared Mar 10, 1986
GAMMA-FREE HORSE SERUM
K860762
Flow Laboratories, Inc.
Pathology · 10d

About Product Code KIS - Regulatory Context