JJW · Class I · 21 CFR 862.1660

FDA Product Code JJW: Urinalysis Controls (assayed And Unassayed)

Leading manufacturers include Medical Analysis Systems, Inc., Bio-Rad and Miles Laboratories, Inc..

61
Total
61
Cleared
61d
Avg days
1976
Since
61 devices
49–61 of 61
Cleared Aug 08, 1983
BIOCHECK POSITIVE URINE CONTROL
K831994
Helena Laboratories
Chemistry · 48d
Cleared Apr 12, 1983
NEGATIVE URINE CONTROL
K830834
Helena Laboratories
Chemistry · 27d
Cleared Oct 08, 1982
COUNT-10 TROL
K822540
Texas Immunology, Inc.
Chemistry · 46d
Cleared Apr 14, 1981
KOVA TROL I HUMAN URINE (DRIED)
K810917
Icl Scientific
Chemistry · 8d
Cleared Dec 06, 1979
QUANTITATIVE CONTROL URINE I (HUMAN)
K792374
Environmental Chemical Specialties
Chemistry · 10d
Cleared Dec 06, 1979
QUANTITATIVE CONTROL URINE II (HUMAN)
K792376
Environmental Chemical Specialties
Chemistry · 10d
Cleared Feb 08, 1979
CONTROL STRIP FOR VISUAL URINALYSIS
K781961
Miles Laboratories, Inc.
Chemistry · 79d
Cleared Dec 20, 1978
CHEMSTRIP CONTROL
K781691
Boehringer Mannheim Corp.
Chemistry · 77d
Cleared Jun 13, 1978
ARMTROL AND FERMTROL
K780802
Biotron , Ltd.
Chemistry · 33d
Cleared May 03, 1978
KOVA TROL III
K780482
Icl Scientific
Chemistry · 37d
Cleared Oct 18, 1977
TEK-CHEK-2
K771713
Miles Laboratories, Inc.
Chemistry · 36d
Cleared May 03, 1977
URINALYSIS PROFICIENCY
K770390
Miles Laboratories, Inc.
Chemistry · 64d
Cleared Nov 02, 1976
PRODUCT #K3002 KETOTROL-N(URINE CONTROL)
K760863
Sigma Chemical Co.
Chemistry · 15d