Medical Device Manufacturer · US , Mchenry , IL

Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices

340 submissions · 340 cleared · Since 1976
340
Total
340
Cleared
0
Denied
340 devices
251-275 of 340
Cleared Mar 28, 1986
ENZYMUN-TEST FERRITIN
K860137 · DBF
Immunology · 73d
Cleared Jan 17, 1986
CREATININE PAP
K854766 · JFY
Chemistry · 51d
Cleared Jan 17, 1986
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
K855225 · JJX
Chemistry · 18d
Cleared Nov 19, 1985
ES 22
K854243 · JJE
Chemistry · 29d
Cleared Nov 12, 1985
IRON
K854298 · CEM
Chemistry · 18d
Cleared Oct 28, 1985
HITACHI 704
K854025 · JJE
Chemistry · 28d
Cleared Sep 16, 1985
REFLOTRON SYSTEM
K852133 · JJE
Chemistry · 123d
Cleared Aug 01, 1985
ACCU-CHEK II
K851456 · CGA
Chemistry · 112d
Cleared Jul 05, 1985
PRECINORM HB
K852136 · GGM
Hematology · 50d
Cleared Mar 12, 1985
UROTRON RL9
K850348 · JJQ
Chemistry · 43d
Cleared Mar 11, 1985
PERIDOCHROM TRIGLYCERIDES GPO
K850667 · CDT
Chemistry · 19d
Cleared Mar 05, 1985
PRECINORM H & PRECIPATH H
K850017 · JJY
Chemistry · 62d
Cleared Feb 06, 1985
CALCIUM
K850281 · CIC
Chemistry · 14d
Cleared Jan 07, 1985
ALBUMIN BCP
K844426 · CJW
Immunology · 53d
Cleared Jan 07, 1985
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE
K844655 · CHH
Chemistry · 39d
Cleared Dec 12, 1984
80 MG/DL GLUCOSE CONTROL
K844581 · JIS
Chemistry · 19d
Cleared Oct 05, 1984
BOEHRINGER MANNHEIM DIAGNOSTICS ADAM
K843283 · JJE
Chemistry · 46d
Cleared Sep 28, 1984
PRECISET AMMONIA
K843569 · JJX
Chemistry · 18d
Cleared Aug 29, 1984
UNIVERSAL 2 S CENTRIFUGE
K843087 · JQC
Chemistry · 23d
Cleared Aug 29, 1984
EBA 3 S CENTRIFUGE
K843088 · JQC
Chemistry · 23d
Cleared Aug 16, 1984
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393 · CGA
Chemistry · 59d
Cleared Jun 22, 1984
REFLOCHECK-S
K840962 · CGA
Chemistry · 108d
Cleared Feb 13, 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · CGA
Chemistry · 67d
Cleared Nov 25, 1983
REAGENT SET TRIGLYCERIDES GPO
K833082 · CDT
Chemistry · 74d
Cleared Oct 28, 1983
SPIROMETER ISOLATION VALVE #8890
K833088 · CAI
Anesthesiology · 46d

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