KIS · Class I · 21 CFR 864.2800

FDA Product Code KIS: Sera, Animal And Human

Leading manufacturers include Dutchland Laboratories, Inc., Hazleton Research Products, Inc. and Flow Laboratories, 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 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
Cleared Oct 01, 1984
FETAL BOVINE SERUM, F4884 STERILE GROWT
K843629
Sigma Chemical Co.
Pathology · 17d
Cleared Sep 08, 1981
GUINEA PIG SERUM - STERILE
K812379
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
RABBIT SERUM - STERILE
K812380
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
DONOR HORSE SERUM - STERILE
K812381
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
DONOR CALF (BOVINE-SERUM) - STERILE
K812382
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
CALF (BOVINE) SERUM - STERILE
K812383
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
NEWBORN CALF SERUM - STERILE
K812384
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
NATAL CALF (BOVINE) SERUM - STERILE
K812385
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
FETAL BOVINE SERUM - STERILE
K812386
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared May 08, 1981
GOAT SERUM-STERILE
K810775
Dutchland Laboratories, Inc.
Chemistry · 46d

About Product Code KIS - Regulatory Context