Company ยท US
Technostics Intl.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1986. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFD | Sulfophosphovanillin, Colorimetry, Total Lipids | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGE | Orthotoluidine, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CIQ | Diazo, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 |
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 1986 | K855188 | CPK (UV) REAGENT KIT Technostics Intl. | JHS |
| Feb 19, 1986 | K860111 | URIC ACID REAGENT SET Technostics Intl. | LFQ |
| Feb 18, 1986 | K855190 | MAGNESIUM REAGENT SET Technostics Intl. | JGJ |
| Feb 11, 1986 | K860110 | GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET Technostics Intl. | CKA |
| Feb 6, 1986 | K860109 | ENZYMATIC UREA NITROGEN REAGENT SET Technostics Intl. | CDQ |
| Jan 24, 1986 | K860112 | TOTAL LIPIDS REAGENT SET Technostics Intl. | CFD |
| Jan 22, 1986 | K855185 | GLUCOSE REAGENT SET Technostics Intl. | CGE |
| Jan 21, 1986 | K855157 | LACTIC DEHYDROGENASE (VV) REAGENT SET Technostics Intl. | CFJ |
| Jan 14, 1986 | K855195 | DIRECT & TOTAL BILIRUBIN SET Technostics Intl. | CIG |
| Jan 14, 1986 | K855194 | GLUCOSE OXIDASE REAGENT SET Technostics Intl. | CGA |
| Jan 14, 1986 | K855193 | CREATININE REAGENT SET Technostics Intl. | CGX |
| Jan 14, 1986 | K855192 | ALKALINE PHOSPHATASE REAGENT SET Technostics Intl. | CIO |
| Jan 14, 1986 | K855191 | TOTAL PROTEIN REAGENT SET Technostics Intl. | CEK |
| Jan 14, 1986 | K855189 | GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET Technostics Intl. | CIQ |
| Jan 14, 1986 | K855187 | ENZYMATIC CHOLESTROL REAGENT SET Technostics Intl. | CHH |
| Jan 14, 1986 | K855186 | GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET Technostics Intl. | JPZ |
| Jan 14, 1986 | K855159 | LACTIC DEHYDROGENASE REAGENT SET Technostics Intl. | CFJ |
| Jan 14, 1986 | K855158 | ALBUMIN REAGENT SET Technostics Intl. | CIX |
| Jan 14, 1986 | K855156 | GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET Technostics Intl. | JPZ |
| Jan 14, 1986 | K855154 | INORGANIC PHOSPHORUS REAGENT SET Technostics Intl. | CEO |
| Jan 14, 1986 | K855153 | GLUCOSE (UV HEXOKIASE) REAGENT SET Technostics Intl. | CFR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||