Medical Device Manufacturer · US , Mchenry , IL

Advanced Biomedical Methods, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1976
21
Total
21
Cleared
0
Denied

FDA 510(k) Regulatory Record - Advanced Biomedical Methods, Inc. Chemistry

20 devices
1-20 of 20
Cleared Dec 09, 1994
CLARIT(TM)
K945353 · JKA
Chemistry · 50d
Cleared Apr 05, 1988
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
K880949 · CJY
Chemistry · 29d
Cleared Mar 16, 1987
RESUBMISSION OF THE KLEERZIT REAGENT
K864866 · JKA
Chemistry · 95d
Cleared Jul 22, 1985
SGOT/ALT REAGENT
K852783 · CIT
Chemistry · 21d
Cleared Jul 22, 1985
ALKALINE PHOSPHATASE
K852784 · CJE
Chemistry · 21d
Cleared Mar 01, 1985
LDH REAGENT FOR DEMAND ANALYZER
K850378 · CFJ
Chemistry · 29d
Cleared Mar 01, 1985
DIRECT BILIRUBIN FOR DEMAND ANALYZER
K850379 · CIG
Chemistry · 29d
Cleared Mar 01, 1985
INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER
K850380 · CEO
Chemistry · 29d
Cleared Mar 01, 1985
MAGNESIUM REAGENT FOR DEMAND ANALYZER
K850381 · JGJ
Chemistry · 29d
Cleared Jan 03, 1985
CALCIUM REAGENT FOR DEMAND ANALYZER
K844241 · CIC
Chemistry · 63d
Cleared Jan 03, 1985
CHOLESTEROL REAGENT FOR DEMAND ANALYZER
K844242 · CHH
Chemistry · 63d
Cleared Jan 03, 1985
TOTAL BILIRUBIN FOR DEMAND ANALYZER
K844243 · CIC
Chemistry · 63d
Cleared Jan 03, 1985
ALBUMIN REAGENT FOR DEMAND ANALYZER
K844330 · CIX
Chemistry · 57d
Cleared Jan 03, 1985
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
K844331 · CEK
Chemistry · 57d
Cleared Jan 03, 1985
CREATININE REAGENT FOR DEMAND ANALYZER
K844332 · CGX
Chemistry · 57d
Cleared Dec 10, 1984
ISE REAGENTS FOR DEMAND ANALYZER
K844021 · CGZ
Chemistry · 56d
Cleared Sep 15, 1977
CHOLOPAP-HDL
K771586 · CHH
Chemistry · 28d
Cleared Dec 09, 1976
S-UREA-N, IN VITRO DIAG FOR BUN
K761152 · CDL
Chemistry · 10d
Cleared Dec 09, 1976
GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE
K761153 · CGA
Chemistry · 10d
Cleared Dec 09, 1976
GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ
K761154 · CGA
Chemistry · 10d
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