JIW · Class II · 21 CFR 862.1150

FDA Product Code JIW: Calibrator, Surrogate

Leading manufacturers include E.I. Dupont DE Nemours & Co., Inc., Boehringer Mannheim Corp. and Sigma Chemical Co..

17
Total
17
Cleared
66d
Avg days
1979
Since

FDA 510(k) Cleared Calibrator, Surrogate Devices (Product Code JIW)

17 devices
1–17 of 17
Cleared Apr 03, 1991
FLOW CYTOMETRY FITC/PE COMPENSATION KIT
K910255
Sigma Diagnostics, Inc.
Hematology · 71d
Cleared Oct 04, 1990
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
K902575
Diagnostic Products Corp.
Chemistry · 115d
Cleared Jul 03, 1990
ACCUSCAN MICROBEAD STANDARDS
K902294
Sigma Chemical Co.
Hematology · 42d
Cleared Mar 24, 1988
UNIMETER CALIBRATION KIT
K880610
Boehringer Mannheim Corp.
Chemistry · 41d
Cleared Jul 08, 1980
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 36d

About Product Code JIW - Regulatory Context