Company ยท US
Sterling Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1993. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDL | Berthelot Indophenol, Urea Nitrogen | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 2 |
| CGA | Glucose Oxidase, Glucose | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| CIQ | Diazo, Ast/Sgot | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 |
| JIY | Photometric Method, Iron (Non-Heme) | 2 |
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion | 2 |
| CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEI | Uranyl Acetate/Zinc Acetate, Sodium | 1 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFG | Oil Emulsion/Thymolphthalein (Titrimetric), Lipase | 1 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CFR | Hexokinase, Glucose | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 21, 1993 | K921412 | MICROPROTEIN REAGENT SET Sterling Diagnostics, Inc. | CEK |
| Nov 7, 1991 | K914609 | TRIGLYCERIDES REAGENT SET Sterling Diagnostics, Inc. | CDT |
| Oct 31, 1991 | K914039 | SODIUM REAGENT SET Sterling Diagnostics, Inc. | CEI |
| Oct 30, 1991 | K914040 | PHOSPHOLIPID REAGENT SET Sterling Diagnostics, Inc. | JNT |
| Jul 29, 1986 | K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) Sterling Diagnostics, Inc. | CFJ |
| Jul 7, 1986 | K861962 | VANILMANDELIC ACID (VMA) REAGENT SET Sterling Diagnostics, Inc. | CDF |
| Jul 1, 1986 | K862256 | ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET Sterling Diagnostics, Inc. | CJE |
| Jul 1, 1986 | K862210 | UREA NITROGEN (GLDH) REAGENT SET (UV) Sterling Diagnostics, Inc. | CDQ |
| Jun 25, 1986 | K862209 | ALT (SGPT) REAGENT SET (UV RATE) Sterling Diagnostics, Inc. | CKA |
| Jun 16, 1986 | K861855 | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET Sterling Diagnostics, Inc. | JKF |
| May 23, 1986 | K861713 | SERUM POTASSIUM REAGENT SET Sterling Diagnostics, Inc. | CEJ |
| May 23, 1986 | K861615 | SALICYLATE REAGENT SET Sterling Diagnostics, Inc. | DKJ |
| Apr 24, 1986 | K861311 | GLUCOSE (HEXOKINASE) REAGENT SET Sterling Diagnostics, Inc. | CFR |
| Apr 24, 1986 | K860350 | SERUM CHOLINESTERASE REAGENT SET Sterling Diagnostics, Inc. | DLI |
| Apr 3, 1986 | K860667 | ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET Sterling Diagnostics, Inc. | CIT |
| Apr 3, 1986 | K860485 | SGPT (ALT) REAGENT SET (COLORIMETRIC) Sterling Diagnostics, Inc. | CKD |
| Apr 3, 1986 | K860477 | URIC ACID REAGNET SET (TRINDER) Sterling Diagnostics, Inc. | KNK |
| Apr 3, 1986 | K860216 | SGOT (AST) REAGENT SET Sterling Diagnostics, Inc. | CIQ |
| Mar 17, 1986 | K860348 | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET Sterling Diagnostics, Inc. | JPZ |
| Mar 17, 1986 | K860214 | TOTAL BILIRUBIN REAGENT SET Sterling Diagnostics, Inc. | CIG |
| Mar 14, 1986 | K860628 | INORGANIC PHOSPHORUS REAGENT SET Sterling Diagnostics, Inc. | CEO |
| Mar 14, 1986 | K860554 | SERUM LIPASE REAGENT SET (TURBIDIMETRIC) Sterling Diagnostics, Inc. | CFG |
| Mar 14, 1986 | K860478 | SERUM IRON & IRON BINDING REAGENT SET Sterling Diagnostics, Inc. | JIY |
| Mar 5, 1986 | K860476 | ACID PHOSPHATASE REAGENT SET Sterling Diagnostics, Inc. | CKE |
| Mar 3, 1986 | K860475 | HEMOGLOBIN REAGENT SET Sterling Diagnostics, Inc. | KHG |
| Feb 28, 1986 | K860530 | AMYLASE REAGENT SET (MODIFIED CARAWAY) Sterling Diagnostics, Inc. | CJA |
| Feb 28, 1986 | K860349 | LACTATE DEHYDROGENASE (LDH) REAGENT SET Sterling Diagnostics, Inc. | CFH |
| Feb 24, 1986 | K860420 | SICKLE CELL REAGENT SET Sterling Diagnostics, Inc. | GHM |
| Feb 19, 1986 | K860340 | SERUM ALBUMIN (BCG) REAGENT SET Sterling Diagnostics, Inc. | CIX |
| Feb 19, 1986 | K855164 | ENZYNATIC TRIGLYCERIDES REAGENT SET Sterling Diagnostics, Inc. | CDT |
| Feb 11, 1986 | K860419 | UREA NITROGEN REAGENT SET Sterling Diagnostics, Inc. | CDW |
| Feb 11, 1986 | K860418 | CREATININE REAGENT SET Sterling Diagnostics, Inc. | CGX |
| Feb 11, 1986 | K860351 | ALKALINE PHOSPHATASE REAGENT SET Sterling Diagnostics, Inc. | CIO |
| Feb 11, 1986 | K860341 | TOTAL PROTEIN (BIURET) REAGENT SET Sterling Diagnostics, Inc. | CEK |
| Feb 11, 1986 | K860215 | MAGNESIUM REAGENT SET Sterling Diagnostics, Inc. | JGJ |
| Feb 11, 1986 | K860142 | URIC ACID REAGENT SET (COLORIMETRIC) Sterling Diagnostics, Inc. | LFQ |
| Feb 11, 1986 | K860096 | CPK REAGENT SET (COLORIMETRIC) Sterling Diagnostics, Inc. | CGS |
| Feb 11, 1986 | K860044 | CALCIUM (CPC) REAGENT SET Sterling Diagnostics, Inc. | CIC |
| Feb 6, 1986 | K860154 | BUN (ENZYMATIC BERTHELOT) REAGENT SET Sterling Diagnostics, Inc. | CDL |
| Jan 28, 1986 | K855028 | TOTAL CHOLESTEROL REAGENT SET Sterling Diagnostics, Inc. | CHH |
| Nov 22, 1985 | K854335 | GLUCOSE REAGENT SET (GOD/TRINDER) Sterling Diagnostics, Inc. | CGA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is Terminated |
LFQ | K860142 |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated |
CDL | K860154 |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated |
CKA | None listed |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated |
CIQ | K860216 |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed Terminated |
JIY | K860478 |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated |
CGA | K854335 |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated |
CGX | K860418 |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed Terminated |
LBR | None listed |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated |
CHH | None listed |