Simmler Inc
Saint Louis, MO, US
SIMMLER, INC. appears in FDA device records in Saint Louis, MO. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Simmler Inc between 1980 and 1989. The busiest year on record is 1987, with 10. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 3 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 3 |
| 1987 | 10 |
| 1988 | 3 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K895745 | SICKLE CELL SOLUBILITY TEST KIT | JBB | Substantially Equivalent | |
| K874903 | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | JPZ | Substantially Equivalent | |
| K874595 | MULTICHEM (R) MAGNESIUM REAGENT | JGJ | Substantially Equivalent | |
| K874820 | MULTICHEM HDL PRECIPITATING REAGENT #S0914 | LBR | Substantially Equivalent | |
| K874812 | MULTICHEM CHLORIDE REAGENT S0933 | CHJ | Substantially Equivalent | |
| K874311 | MULTICHEM (R) TOTAL BILIRUBIN | CIG | Substantially Equivalent | |
| K874049 | MULTICHEM ALBUMIN REAGENT S0902 | CIX | Substantially Equivalent | |
| K874038 | MULTICHEM INORGANIC PHOSPHOROUS S0923 | CEO | Substantially Equivalent | |
| K873725 | MULTICHEM CREATININE REAGENT S0917 | CGX | Substantially Equivalent | |
| K873761 | MULTICHEM ALKALINE PHOSPHATASE (S0903) | CJE | Substantially Equivalent | |
| K873697 | MULTICHEM CALCIUM S0910 | CIC | Substantially Equivalent | |
| K872010 | MULTICHEM LDH-L REAGENT | CFJ | Substantially Equivalent | |
| K871976 | MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 | CFR | Substantially Equivalent | |
| K871975 | MULTICHEM TOTAL PROTEIN REAGENT #S0928 | CEK | Substantially Equivalent | |
| K853244 | TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE | CEK | Substantially Equivalent | |
| K853050 | CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ | CIC | Substantially Equivalent | |
| K853049 | ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE | CIX | Substantially Equivalent | |
| K843938 | LINEAR ENZYMATIC URIC ACID SYSTEM | KNK | Substantially Equivalent | |
| K831700 | MULTICHEM ENZYMATIC CHOLESTEROL SYS | CHH | Substantially Equivalent | |
| K831398 | LINEAR ENZMATIC URIC ACID SYSTEM | KNK | Substantially Equivalent | |
| K801222 | REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER | JIX | Substantially Equivalent | |
| K800200 | LINEAR ENZYMATIC GLUCOSE SYSTEM | CGA | Substantially Equivalent | |
| K800199 | LINEAR ENZYMATIC CHOLESTEROL SYSTEM | CHH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1950226 | 1950226 | SIMMLER, INC. | 2115 59th Street, Saint Louis, MO 63110 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- LBRLdl & Vldl Precipitation, Hdl
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- JBBSolubility, Hemoglobin, Abnormal
- GHQStain, Fetal Hemoglobin
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0653-03 | Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing Solution (80% Reagent Alcohol), 3 x 120ml Fetal Cell Citrate Buffer Solution (Citrate Buffer, 0.081M), and 3 x 120ml Fetal Cell Stain (Erythrosin-B, Fast Green). The responsible firm on the label is Simmler, Inc., St. Louis, MO. | Fixing solution bottles are labeled as buffering solution. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain