KIP · Class I · 21 CFR 864.2875

FDA Product Code KIP: Formulations, Balanced Salt Solutions

Leading manufacturers include Dutchland Laboratories, Inc., Sigma Chemical Co. and E K Ind., Inc..

17
Total
17
Cleared
38d
Avg days
1978
Since

FDA 510(k) Cleared Formulations, Balanced Salt Solutions Devices (Product Code KIP)

17 devices
1–17 of 17
Cleared Mar 30, 1987
(D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030
K870482
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
HANKS' BALANCED SALTS (HBSS) NO. H1387
K870484
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509
K870486
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002
K870491
Sigma Chemical Co.
Pathology · 55d
Cleared Feb 25, 1985
HEPES BUFFER IM IN NORMAL SALINE
K844877
Hazleton Research Products, Inc.
Pathology · 70d
Cleared Feb 25, 1985
TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG
K844878
Hazleton Research Products, Inc.
Microbiology · 70d
Cleared Aug 03, 1984
SALINE, 1.3% W/O PRESERVATIVE
K842723
E K Ind., Inc.
Pathology · 21d
Cleared Aug 03, 1984
SALINE 0.85% W/O PRESERVATIVE
K842724
E K Ind., Inc.
Pathology · 21d
Cleared Aug 03, 1984
SALINE, 0.85%W/PRESERVATIVE
K842725
E K Ind., Inc.
Hematology · 21d
Cleared Apr 21, 1982
DULBECCO'S PBS POWDER
K820923
Dutchland Laboratories, Inc.
Microbiology · 20d
Cleared Apr 21, 1982
HBS POWDER
K820927
Dutchland Laboratories, Inc.
Microbiology · 20d
Cleared Apr 21, 1982
EBS POWDER
K820928
Dutchland Laboratories, Inc.
Microbiology · 20d
Cleared May 13, 1981
EARLE'S BALANCED SALTS SOULTION
K810779
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 08, 1981
HANKS' BALANCED SALT SOLUTION W/O CA-MG
K810766
Dutchland Laboratories, Inc.
Chemistry · 46d
Cleared May 08, 1981
HANKS' BALANCED SALTS SOLUTION (MODIF.)
K810777
Dutchland Laboratories, Inc.
Chemistry · 46d
Cleared Aug 21, 1978
PBS FOR FA (46-991-49)
K781391
Flow Laboratories, Inc.
Microbiology · 11d

About Product Code KIP - Regulatory Context