Company ยท US
Technicon Instruments Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1991. Name variants (Inc, Corp, punctuation) are merged.
157510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | 12 |
| GKL | Counter, Cell, Automated (Particle Counter) | 8 |
| GKZ | Counter, Differential Cell | 6 |
| JGJ | Photometric Method, Magnesium | 6 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 |
| JGS | Electrode, Ion Specific, Sodium | 4 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 4 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 3 |
| CIC | Cresolphthalein Complexone, Calcium | 3 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 3 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 3 |
| JPK | Mixture, Hematology Quality Control | 3 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 2 |
| CFR | Hexokinase, Glucose | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 1991 | K914888 | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) Technicon Instruments Corp. | CIX |
| Nov 27, 1991 | K914511 | TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL Technicon Instruments Corp. | LBS |
| Nov 22, 1991 | K914025 | TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) Technicon Instruments Corp. | CIT |
| Sep 25, 1991 | K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES Technicon Instruments Corp. | KLI |
| Jul 1, 1991 | K912413 | CHEM-LINK DATA BASE MANAGER Technicon Instruments Corp. | JJQ |
| Sep 27, 1990 | K903825 | DRUG OF ABUSE ANALYSIS SYSTEM Technicon Instruments Corp. | DIS |
| Sep 27, 1990 | K903824 | DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY Technicon Instruments Corp. | DKZ |
| Sep 27, 1990 | K903305 | TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD Technicon Instruments Corp. | KHS |
| Aug 29, 1990 | K903306 | TECHNICON CHEM I SYSTEM MAGNESIUM METHOD Technicon Instruments Corp. | JGJ |
| Jul 17, 1990 | K901410 | TECHNICON RA-2000(TM) SYSTEM Technicon Instruments Corp. | JJC |
| Jul 5, 1990 | K902243 | TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES Technicon Instruments Corp. | KLS |
| May 14, 1990 | K901124 | CHEM I CLINICAL ANALYZER URINE MAGNESIUM Technicon Instruments Corp. | JGJ |
| May 10, 1990 | K901123 | CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN Technicon Instruments Corp. | CDQ |
| May 4, 1990 | K901229 | CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) Technicon Instruments Corp. | CGX |
| Apr 26, 1990 | K900943 | MODIFIED TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. | DEW |
| Apr 26, 1990 | K900717 | TECHNICON TESTPOINT(TM) LIGAND CONTROL Technicon Instruments Corp. | JJY |
| Apr 25, 1990 | K901693 | TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC Technicon Instruments Corp. | KNK |
| Apr 19, 1990 | K901226 | CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) Technicon Instruments Corp. | CIC |
| Apr 12, 1990 | K901137 | CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) Technicon Instruments Corp. | CEO |
| Apr 3, 1990 | K900905 | TECHNICON AXON SYSTEM REAGENT METHODS Technicon Instruments Corp. | CKA |
| Mar 29, 1990 | K901122 | TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE Technicon Instruments Corp. | CFR |
| Mar 14, 1990 | K900593 | TECHNICON H*2(TM) SYSTEM Technicon Instruments Corp. | GKZ |
| Feb 23, 1990 | K896829 | TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) Technicon Instruments Corp. | JGT |
| Nov 14, 1989 | K895664 | TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD Technicon Instruments Corp. | CEM |
| Oct 25, 1989 | K895672 | TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD Technicon Instruments Corp. | JGS |
| Oct 17, 1989 | K895808 | TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN Technicon Instruments Corp. | DCF |
| Oct 4, 1989 | K894575 | TECHNICON RA SYSTEM THYROXINE T4 METHOD Technicon Instruments Corp. | CDX |
| Aug 21, 1989 | K893913 | TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD Technicon Instruments Corp. | KLB |
| Aug 21, 1989 | K893912 | TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD Technicon Instruments Corp. | LCD |
| Aug 10, 1989 | K894574 | TECHNICON DPA-1 SYSTEM RF METHOD Technicon Instruments Corp. | DHR |
| Jul 27, 1989 | K892930 | TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES Technicon Instruments Corp. | CKA |
| Jul 20, 1989 | K892929 | TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES Technicon Instruments Corp. | CHJ |
| May 9, 1989 | K892198 | TECHNICON DPA-1 (TM) CRP METHOD Technicon Instruments Corp. | DCK |
| Mar 28, 1989 | K885203 | TECHNICON DAX(TM) SYSTEM Technicon Instruments Corp. | JJG |
| Feb 17, 1989 | K885226 | TECHNICON AXON(TM) SYSTEM Technicon Instruments Corp. | JJE |
| Jan 30, 1989 | K884748 | TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) Technicon Instruments Corp. | JFH |
| Jan 30, 1989 | K884747 | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) Technicon Instruments Corp. | CKB |
| Jan 27, 1989 | K884601 | TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE Technicon Instruments Corp. | CHJ |
| Jan 27, 1989 | K884599 | TECHNICON RA-100 SYSTEM CALCIUM METHOD Technicon Instruments Corp. | CIC |
| Jan 23, 1989 | K884600 | TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM Technicon Instruments Corp. | JGJ |
| Nov 29, 1988 | K884433 | TECHNICON ASSIST(R) CALCIUM METHOD Technicon Instruments Corp. | CIC |
| Nov 29, 1988 | K883586 | TECHNICON RA-100 SYSTEM POTASSIUM Technicon Instruments Corp. | CEJ |
| Nov 29, 1988 | K883585 | TECHNICON ASSIST POTASSIUM Technicon Instruments Corp. | CEJ |
| Nov 22, 1988 | K884419 | TECHNICON RA-PHENOBARBITAL Technicon Instruments Corp. | DLZ |
| Nov 4, 1988 | K884217 | TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN Technicon Instruments Corp. | LKL |
| Oct 25, 1988 | K883104 | CHEM 1 UIBC (IRON BINDING CAPACITY TEST) Technicon Instruments Corp. | JMO |
| Oct 13, 1988 | K883326 | TECHNICON RA(TM) SYSTEMS - MAGNESIUM Technicon Instruments Corp. | JGJ |
| Sep 22, 1988 | K883493 | TECHNICON DPA-1 IMMUNOGLOBULIN M Technicon Instruments Corp. | DFL |
| Sep 22, 1988 | K883492 | TECHNICON DPA-1 IMMUNOGLOBULIN A Technicon Instruments Corp. | CZP |
| Sep 13, 1988 | K883209 | TECHNICON RA-100(TM) SYSTEM Technicon Instruments Corp. | JJE |
Newest 50 of 157.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||