Synermed, Inc.
Quebec, Canada, CA
Synermed, Inc. appears in FDA device records in Quebec, Canada, CA. FDA records list 45 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 45
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 45 510(k) clearances for Synermed, Inc. between 1990 and 1997. The busiest year on record is 1990, with 15. The most recent is 1997, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 15 |
| 1991 | 3 |
| 1992 | 7 |
| 1993 | 5 |
| 1994 | 7 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973109 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT | CIG | Substantially Equivalent | |
| K972716 | SYNERMED TOTAL BILIRUBIN REAGENT KIT | CIG | Substantially Equivalent | |
| K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER | JJF | Substantially Equivalent | |
| K962479 | SYNERMED ISE REAGENTS | CGZ | Substantially Equivalent | |
| K963939 | SYNERMED DIRECT BILIRUBIN REAGENT KIT | CIG | Substantially Equivalent | |
| K960793 | SYNERMED ENZYMATIC CO2 REAGENT KIT | KHS | Substantially Equivalent | |
| K953395 | SYNERMED CALCIUM REAGENT KIT | CJY | Substantially Equivalent | |
| K952179 | SYNERMED ISE REAGENTS | JGS | Substantially Equivalent | |
| K943924 | CREATININE-PO REAGENT KIT | CGX | Substantially Equivalent | |
| K941091 | SYNERMED AMYLASE REAGENT KIT | JFJ | Substantially Equivalent | |
| K941400 | SYNERMED ISE REAGENTS | JGS | Substantially Equivalent | |
| K935662 | SYNERMED IR 500 CHEMISTRY ANALYZER | JIQ | Substantially Equivalent | |
| K940571 | SYNERMEDIR CAL I AND SYNERMED IR CAL II | JIX | Substantially Equivalent | |
| K940570 | SYNERMED TOTAL BILIRUBIN REAGENT KIT | CIG | Substantially Equivalent | |
| K940194 | SYNERMED ISE REAGENTS | JGS | Substantially Equivalent | |
| K933026 | SYNERMED DIRECT BILIRUBIN REAGENT KIT | CIG | Substantially Equivalent | |
| K931986 | AMP ALKALINE PHOSPHATASE REAGENT KIT | CJE | Substantially Equivalent | |
| K931958 | SYNERMED GGT REAGENT KIT | JQB | Substantially Equivalent | |
| K930932 | SYNERMED CREATINE KINASE REAGENT KIT | CGS | Substantially Equivalent | |
| K926511 | SYNERMED SINGLE REAGENT CREATININE KIT | CGX | Substantially Equivalent | |
| K924428 | SYNERMED ENZYMATIC CO2 REAGENT KIT | KHS | Substantially Equivalent | |
| K924427 | SYNERMED HDL CHOLESTLEROL REAGENT KIT | LBR | Substantially Equivalent | |
| K923414 | SYNERMED 600 NM URIC ACID REAGENT KIT | KNK | Substantially Equivalent | |
| K922784 | SYNERMED UIBC REAGENT KIT | JMO | Substantially Equivalent | |
| K921016 | SYNERMED ALT/GPT REAGENT KIT | CKA | Substantially Equivalent | |
| K921025 | SYNERMED LDHH-L REAGENT KIT | CFJ | Substantially Equivalent | |
| K915555 | SYNERMED AST/GOT REAGENT KIT | CIT | Substantially Equivalent | |
| K912912 | SYNERMED SERUM IRON-600 REAGENT KIT | CFM | Substantially Equivalent | |
| K912569 | SYNERMED PHOSPHORUS REAGENT KIT | CEO | Substantially Equivalent | |
| K911248 | SYNERMED UREA NITROGEN REAGENT KIT | CDQ | Substantially Equivalent | |
| K903773 | SYNERMED LDH REAGENT KIT | CFJ | Substantially Equivalent | |
| K903543 | SYNERMED ALBUMIN REAGENT KIT | CIX | Substantially Equivalent | |
| K903233 | SYNERMED CALCIUM REAGENT KIT | CIC | Substantially Equivalent | |
| K903015 | SYNERMED CHOLESTEROL REAGENT KIT | CHH | Substantially Equivalent | |
| K904030 | SYNERMED ALKALINE PHOSPHATASE REAGENT KIT | CJE | Substantially Equivalent | |
| K903727 | SYNERMED URIC ACID REAGENT KIT | KNK | Substantially Equivalent | |
| K903728 | SYNERMED DIRECT BILIRUBIN REAGENT KIT | CIG | Substantially Equivalent | |
| K903063 | SYNERMED GLUCOSE REAGENT KIT | CGA | Substantially Equivalent | |
| K903511 | SYNERMED TOTAL PROTEIN REAGENT KIT | CEK | Substantially Equivalent | |
| K903296 | SYNERMED CREATININE REAGENT KIT | CGX | Substantially Equivalent | |
| K903103 | SYNERMED CHLORIDE REAGENT KIT | CHG | Substantially Equivalent | |
| K902919 | SYNERMED MAGNESIUM REAGENT KIT | JGJ | Substantially Equivalent | |
| K902918 | SYNERMED SERUM IRON REAGENT KIT | CFM | Substantially Equivalent | |
| K903016 | SYNERMED TRIGLYCERIDES REAGENT KIT | CDT | Substantially Equivalent | |
| K902328 | SYNERMED TOTAL BILIRUBIN REAGENT KIT | CIG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CHGAcid, Phosphoric-Tungstic (Spectrophotometric), Chloride
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- CJYAzo Dye, Calcium
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JFJCatalytic Methods, Amylase
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KHSEnzymatic, Carbon-Dioxide
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- CGAGlucose Oxidase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain