KSG · Class II · 21 CFR 864.9600

FDA Product Code KSG: Media, Potentiating For In Vitro Diagnostic Use

Leading manufacturers include Ortho Diagnostics, Inc., Pfizer, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

13
Total
13
Cleared
28d
Avg days
1978
Since

FDA 510(k) Cleared Media, Potentiating For In Vitro Diagnostic Use Devices (Product Code KSG)

13 devices
1–13 of 13
Cleared May 08, 1980
PENTEX BOVINE ALBUMIN 30% SOLUTION
K800943
Miles Laboratories, Inc.
Hematology · 16d
Cleared Oct 11, 1979
ORTHO ANTIBODY ENHANCEMENT SOLUTION
K791791
Ortho Diagnostics, Inc.
Hematology · 30d
Cleared Jun 28, 1979
LOW IONIC STRENGTH SOLUTION (LISS)
K791113
Hyland Therapeutic Div., Travenol Laboratories
Hematology · 13d
Cleared Jun 15, 1979
LO-ION
K790973
Gamma Biologicals, Inc.
Hematology · 23d
Cleared May 23, 1979
DADE LOW IONIC STRENGTH SOLUITION (LISS)
K790776
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 33d
Cleared Apr 03, 1979
LISS REAGENT
K790498
Fisher Scientific Co., LLC
Hematology · 21d
Cleared Sep 14, 1978
ORTHO LOW IONIC SOLUTION
K781435
Ortho Diagnostics, Inc.
Hematology · 29d
Cleared Apr 24, 1978
LOW IIONIC STRENGTH SOLUTION
K780413
Pfizer, Inc.
Hematology · 40d
Cleared Apr 24, 1978
SPECT RIM (LISS)
K780556
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 19d

About Product Code KSG - Regulatory Context