Company ยท CA
Synermed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1997. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 7 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 |
| JGS | Electrode, Ion Specific, Sodium | 3 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 2 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 |
| CHG | Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 1997 | K973109 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Aug 7, 1997 | K972716 | SYNERMED TOTAL BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Jun 26, 1997 | K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER Synermed, Inc., CA | JJF |
| Mar 3, 1997 | K962479 | SYNERMED ISE REAGENTS Synermed, Inc., CA | CGZ |
| Dec 18, 1996 | K963939 | SYNERMED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Mar 11, 1996 | K960793 | SYNERMED ENZYMATIC CO2 REAGENT KIT Synermed, Inc., CA | KHS |
| Aug 31, 1995 | K953395 | SYNERMED CALCIUM REAGENT KIT Synermed, Inc., CA | CJY |
| Jun 20, 1995 | K952179 | SYNERMED ISE REAGENTS Synermed, Inc., CA | JGS |
| Sep 20, 1994 | K943924 | CREATININE-PO REAGENT KIT Synermed, Inc., CA | CGX |
| May 3, 1994 | K941091 | SYNERMED AMYLASE REAGENT KIT Synermed, Inc., CA | JFJ |
| Apr 26, 1994 | K941400 | SYNERMED ISE REAGENTS Synermed, Inc., CA | JGS |
| Apr 26, 1994 | K935662 | SYNERMED IR 500 CHEMISTRY ANALYZER Synermed, Inc., CA | JIQ |
| Apr 21, 1994 | K940571 | SYNERMEDIR CAL I AND SYNERMED IR CAL II Synermed, Inc., CA | JIX |
| Apr 20, 1994 | K940570 | SYNERMED TOTAL BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Apr 5, 1994 | K940194 | SYNERMED ISE REAGENTS Synermed, Inc., CA | JGS |
| Oct 28, 1993 | K933026 | SYNERMED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Sep 8, 1993 | K931986 | AMP ALKALINE PHOSPHATASE REAGENT KIT Synermed, Inc., CA | CJE |
| Sep 8, 1993 | K931958 | SYNERMED GGT REAGENT KIT Synermed, Inc., CA | JQB |
| May 11, 1993 | K930932 | SYNERMED CREATINE KINASE REAGENT KIT Synermed, Inc., CA | CGS |
| Feb 18, 1993 | K926511 | SYNERMED SINGLE REAGENT CREATININE KIT Synermed, Inc., CA | CGX |
| Dec 3, 1992 | K924428 | SYNERMED ENZYMATIC CO2 REAGENT KIT Synermed, Inc., CA | KHS |
| Nov 9, 1992 | K924427 | SYNERMED HDL CHOLESTLEROL REAGENT KIT Synermed, Inc., CA | LBR |
| Sep 22, 1992 | K923414 | SYNERMED 600 NM URIC ACID REAGENT KIT Synermed, Inc., CA | KNK |
| Jul 21, 1992 | K922784 | SYNERMED UIBC REAGENT KIT Synermed, Inc., CA | JMO |
| May 7, 1992 | K921016 | SYNERMED ALT/GPT REAGENT KIT Synermed, Inc., CA | CKA |
| Mar 23, 1992 | K921025 | SYNERMED LDHH-L REAGENT KIT Synermed, Inc., CA | CFJ |
| Jan 27, 1992 | K915555 | SYNERMED AST/GOT REAGENT KIT Synermed, Inc., CA | CIT |
| Jul 30, 1991 | K912912 | SYNERMED SERUM IRON-600 REAGENT KIT Synermed, Inc., CA | CFM |
| Jul 17, 1991 | K912569 | SYNERMED PHOSPHORUS REAGENT KIT Synermed, Inc., CA | CEO |
| Jun 3, 1991 | K911248 | SYNERMED UREA NITROGEN REAGENT KIT Synermed, Inc., CA | CDQ |
| Oct 12, 1990 | K903773 | SYNERMED LDH REAGENT KIT Synermed, Inc., CA | CFJ |
| Oct 12, 1990 | K903543 | SYNERMED ALBUMIN REAGENT KIT Synermed, Inc., CA | CIX |
| Oct 4, 1990 | K903233 | SYNERMED CALCIUM REAGENT KIT Synermed, Inc., CA | CIC |
| Oct 1, 1990 | K903015 | SYNERMED CHOLESTEROL REAGENT KIT Synermed, Inc., CA | CHH |
| Sep 27, 1990 | K904030 | SYNERMED ALKALINE PHOSPHATASE REAGENT KIT Synermed, Inc., CA | CJE |
| Sep 27, 1990 | K903727 | SYNERMED URIC ACID REAGENT KIT Synermed, Inc., CA | KNK |
| Sep 21, 1990 | K903728 | SYNERMED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Sep 13, 1990 | K903063 | SYNERMED GLUCOSE REAGENT KIT Synermed, Inc., CA | CGA |
| Sep 7, 1990 | K903511 | SYNERMED TOTAL PROTEIN REAGENT KIT Synermed, Inc., CA | CEK |
| Aug 17, 1990 | K903296 | SYNERMED CREATININE REAGENT KIT Synermed, Inc., CA | CGX |
| Aug 9, 1990 | K903103 | SYNERMED CHLORIDE REAGENT KIT Synermed, Inc., CA | CHG |
| Jul 31, 1990 | K902919 | SYNERMED MAGNESIUM REAGENT KIT Synermed, Inc., CA | JGJ |
| Jul 31, 1990 | K902918 | SYNERMED SERUM IRON REAGENT KIT Synermed, Inc., CA | CFM |
| Jul 27, 1990 | K903016 | SYNERMED TRIGLYCERIDES REAGENT KIT Synermed, Inc., CA | CDT |
| Jun 28, 1990 | K902328 | SYNERMED TOTAL BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||