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 Helena Laboratories.

61
Total
61
Cleared
61d
Avg days
1976
Since
61 devices
25–48 of 61
Cleared Apr 10, 1989
BIOTROL CHEMISTRY URINE CONTROL
K891286
Biotrol, USA, Inc.
Chemistry · 32d
Cleared Mar 08, 1989
MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
K890534
Fisher Scientific Co., LLC
Chemistry · 41d
Cleared Dec 15, 1988
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
K884424
Bio-Rad
Chemistry · 56d
Cleared Mar 16, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
K880496
Bio-Rad
Chemistry · 41d
Cleared Mar 15, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
K880495
Bio-Rad
Chemistry · 40d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG URINGE CONTROLS
K863127
Abbott Laboratories
Chemistry · 31d
Cleared Jul 07, 1986
V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II
K861756
Texas Immunology, Inc.
Chemistry · 62d
Cleared Oct 05, 1984
KOVA TROL I,II, III HUMAN URINE-DRIED
K843565
Icl Scientific
Chemistry · 25d
Cleared Sep 12, 1984
OXALATE URINE CONTROLS NORMAL & ELEVAT
K842366
Sigma Chemical Co.
Chemistry · 89d
Cleared May 01, 1984
BIOSURE
K840848
Helena Laboratories
Hematology · 67d
Cleared Aug 12, 1983
URINE TOTAL PROTEIN CONTROL
K831526
Quantimetrix Corp.
Chemistry · 92d
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 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 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