FDA Product Code JIW: Calibrator, Surrogate
Leading manufacturers include Union Carbide Corp., Sigma Chemical Co. and Diagnostic Products Corp..
17
Total
17
Cleared
66d
Avg days
1979
Since
FDA 510(k) Cleared Calibrator, Surrogate Devices (Product Code JIW)
17 devices
Cleared
Sep 25, 1997
WAKO CH50 LINEARITY SET
Wako Chemicals USA, Inc.
Immunology
41d
Cleared
Feb 20, 1997
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
Dade Chemistry Systems, Inc.
Chemistry
17d
Cleared
Apr 03, 1991
FLOW CYTOMETRY FITC/PE COMPENSATION KIT
Sigma Diagnostics, Inc.
Hematology
71d
Cleared
Oct 04, 1990
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
Diagnostic Products Corp.
Chemistry
115d
Cleared
Jul 03, 1990
ACCUSCAN MICROBEAD STANDARDS
Sigma Chemical Co.
Hematology
42d
Cleared
Jun 21, 1989
ACS COLLOID OSMOTIC PRESSURE CALIBRATOR
Analytical Control Systems, Inc.
Chemistry
79d
Cleared
Dec 14, 1988
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
Reagents Applications, Inc.
Chemistry
126d
Cleared
Aug 02, 1988
CALIBRATION KIT
King Diagnostics, Inc.
Chemistry
68d
Cleared
Jun 07, 1988
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
American Research Products Co.
Chemistry
111d
Cleared
Mar 24, 1988
UNIMETER CALIBRATION KIT
Boehringer Mannheim Corp.
Chemistry
41d
Cleared
Jul 22, 1985
QUICK-CHEM CALIBRATION SET
Seragen Diagnostics, Inc.
Chemistry
59d
Cleared
Aug 18, 1981
NEPHELOMETRIC SOLID TURBIDITY STANDARD
Hyland Therapeutic Div., Travenol Laboratories
Immunology
12d
Cleared
Jul 08, 1980
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
E.I. Dupont DE Nemours & Co., Inc.
Chemistry
36d
Cleared
Mar 12, 1980
CENTRIFICHEM FILTER CALIBRATION SET
Union Carbide Corp.
Chemistry
29d
Cleared
May 23, 1979
CENTRIFICHEM FILTER CALIBRATION SET
Union Carbide Corp.
Chemistry
54d