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Panels › Clinical Chemistry › Product code JJW · Class 1

Urinalysis Controls (Assayed And Unassayed)

Regulation 862.1660

0510(k)s in 12 months (61 all time)
1recalls in 12 months (22 all time)
17recalls that name a 510(k)
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Top companies in JJW

Company510(k)sRecalls
Siemens Healthcare Diagnostics Inc07
Medical Analysis Systems, Inc.60
Bio-Rad50
Quantimetrix Corp.22
Beckman Coulter, Inc.03
Helena Laboratories30
Icl Scientific30
Iris Diagnostics12
Miles Laboratories, Inc.30
Randox Laboratories Limited21
Decided510(k)Device and applicantCode
Oct 8, 1982K822540COUNT-10 TROL
Texas Immunology, Inc.
JJW
Apr 14, 1981K810917KOVA TROL I HUMAN URINE (DRIED)
Icl Scientific
JJW
Dec 6, 1979K792376QUANTITATIVE CONTROL URINE II (HUMAN)
Environmental Chemical Specialties
JJW
Dec 6, 1979K792374QUANTITATIVE CONTROL URINE I (HUMAN)
Environmental Chemical Specialties
JJW
Feb 8, 1979K781961CONTROL STRIP FOR VISUAL URINALYSIS
Miles Laboratories, Inc.
JJW
Dec 20, 1978K781691CHEMSTRIP CONTROL
Boehringer Mannheim Corp.
JJW
Jun 13, 1978K780802ARMTROL AND FERMTROL
Biotron , Ltd.
JJW
May 3, 1978K780482KOVA TROL III
Icl Scientific
JJW
Oct 18, 1977K771713TEK-CHEK-2
Miles Laboratories, Inc.
JJW
May 3, 1977K770390URINALYSIS PROFICIENCY
Miles Laboratories, Inc.
JJW
Nov 2, 1976K760863PRODUCT #K3002 KETOTROL-N(URINE CONTROL)
Sigma Chemical Co.
JJW

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