Medical Device Manufacturer · US , Mchenry , IL

Coulter Electronics, Inc. - FDA 510(k) Cleared Devices

101 submissions · 101 cleared · Since 1976
101
Total
101
Cleared
0
Denied
43 devices
26-43 of 43
Cleared Oct 31, 1980
COULTER DACOS SERUM CHEM. ANALYZER
K802320 · JJE
Chemistry · 38d
Cleared Mar 19, 1980
REFRIG. CENTRIFUGE (DRUCKER MODEL)
K800381 · JQC
Chemistry · 26d
Cleared Dec 06, 1979
COULTER HDL CHOLESTEROL REAG. SYSTEM
K792319 · LBS
Chemistry · 17d
Cleared Sep 24, 1979
COULTER ACCU-ZYME II ENZYMATIC REAGENT
K791640 · CDT
Chemistry · 34d
Cleared Jun 28, 1979
COULTER ACCU-ZYME IIY-GT REAGENT KIT
K790812 · JPZ
Chemistry · 63d
Cleared May 03, 1979
COULTER ACCU-ZYME II GOT REAGENT
K790483 · CIT
Chemistry · 55d
Cleared May 01, 1979
COULTER ACCU-ZYME II GPT REAGENT
K790522 · CKA
Chemistry · 53d
Cleared Sep 27, 1978
COULTER ELECTROLYTE ANALYZER SYSTEM
K781528 · JJE
Chemistry · 22d
Cleared Aug 21, 1978
BUN (UREASE) REAGENT
K781253 · CDN
Chemistry · 31d
Cleared Jul 28, 1978
ENZYMATIC REAGENT FOR CHOLESTEROL MEAS
K781013 · CHH
Chemistry · 42d
Cleared Apr 24, 1978
THYRO-ZYME-T4 ASSAY KIT
K780401 · CDX
Chemistry · 42d
Cleared Nov 09, 1977
COUNTER MODEL S PLUS BLOOD CELL COUNTER
K771512 · GKL
Chemistry · 93d
Cleared Aug 22, 1977
KEM-O-MAT
K771513 · JJF
Chemistry · 14d
Cleared Jun 17, 1977
REAGENT, CHLORIDE, COULTER
K770752 · CHJ
Chemistry · 53d
Cleared May 03, 1977
CHEMISTRY, COULTER
K770679 · JJE
Chemistry · 22d
Cleared Aug 03, 1976
NDC#12739-0011-1 C-ZYME GOT
K760193 · CIT
Chemistry · 28d
Cleared Aug 03, 1976
NDC#12739-0010-1 C-ZYME GPT
K760194 · CKA
Chemistry · 28d
Cleared Aug 03, 1976
REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1
K760195 · CDT
Chemistry · 28d
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