Simmler, Inc. - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Simmler, Inc. Chemistry ✕
21 devices
Cleared
Feb 11, 1988
MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)
Chemistry
72d
Cleared
Jan 07, 1988
MULTICHEM HDL PRECIPITATING REAGENT #S0914
Chemistry
44d
Cleared
Dec 18, 1987
MULTICHEM CHLORIDE REAGENT S0933
Chemistry
24d
Cleared
Nov 25, 1987
MULTICHEM (R) TOTAL BILIRUBIN
Chemistry
36d
Cleared
Oct 29, 1987
MULTICHEM ALBUMIN REAGENT S0902
Chemistry
24d
Cleared
Oct 28, 1987
MULTICHEM INORGANIC PHOSPHOROUS S0923
Chemistry
23d
Cleared
Oct 20, 1987
MULTICHEM CREATININE REAGENT S0917
Chemistry
35d
Cleared
Oct 07, 1987
MULTICHEM ALKALINE PHOSPHATASE (S0903)
Chemistry
21d
Cleared
Oct 02, 1987
MULTICHEM CALCIUM S0910
Chemistry
18d
Cleared
Jun 11, 1987
MULTICHEM LDH-L REAGENT
Chemistry
16d
Cleared
Jun 05, 1987
MULTICHEM TOTAL PROTEIN REAGENT #S0928
Chemistry
14d
Cleared
Jun 05, 1987
MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919
Chemistry
14d
Cleared
Aug 12, 1985
TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE
Chemistry
11d
Cleared
Aug 02, 1985
ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE
Chemistry
14d
Cleared
Aug 02, 1985
CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ
Chemistry
14d
Cleared
Oct 30, 1984
LINEAR ENZYMATIC URIC ACID SYSTEM
Chemistry
21d
Cleared
Jul 19, 1983
MULTICHEM ENZYMATIC CHOLESTEROL SYS
Chemistry
56d
Cleared
Jun 08, 1983
LINEAR ENZMATIC URIC ACID SYSTEM
Chemistry
40d
Cleared
Jun 26, 1980
REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER
Chemistry
34d
Cleared
Feb 21, 1980
LINEAR ENZYMATIC CHOLESTEROL SYSTEM
Chemistry
22d
Cleared
Feb 21, 1980
LINEAR ENZYMATIC GLUCOSE SYSTEM
Chemistry
22d