Company ยท US
Medical Specialties, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1995. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JPK | Mixture, Hematology Quality Control | 5 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 3 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGE | Orthotoluidine, Glucose | 1 |
| CHD | Acid, Ferric Ion-Sulfuric, Cholesterol | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CIQ | Diazo, Ast/Sgot | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| CKD | Hydrazone Colorimetry, Alt/Sgpt | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 18, 1995 | K946201 | STAND, INFUSION Medical Specialties, Inc. | FOX |
| Jun 18, 1993 | K931947 | CHECKPOINT Medical Specialties, Inc. | JPK |
| Jan 26, 1993 | K926095 | REFRACTROL-SP Medical Specialties, Inc. | JJX |
| Jan 7, 1993 | K924926 | MSI-HCT Medical Specialties, Inc. | GLK |
| Feb 9, 1990 | K896566 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE Medical Specialties, Inc. | JWY |
| Nov 22, 1988 | K883851 | MSI-CAL 8 Medical Specialties, Inc. | KRZ |
| Nov 22, 1988 | K883850 | MSI-CAL 16 Medical Specialties, Inc. | KRZ |
| Nov 22, 1988 | K883703 | MSI-CAL 7 Medical Specialties, Inc. | KRZ |
| Mar 21, 1988 | K880608 | MSI-PC Medical Specialties, Inc. | GJP |
| Mar 1, 1988 | K880270 | MSI-DIFF PLUS Medical Specialties, Inc. | JPK |
| Jun 15, 1987 | K872140 | (MSI) PATH-SAVER Medical Specialties, Inc. | IFP |
| Mar 25, 1987 | K871067 | MSI HEMATOLOGY CONTROL + Medical Specialties, Inc. | JPK |
| Apr 7, 1986 | K860501 | FLAME PHOTOMETER STANDARD Medical Specialties, Inc. | JLJ |
| Sep 19, 1985 | K853776 | MSI-HB HEMOGLOBIN CONTROL Medical Specialties, Inc. | JPK |
| May 1, 1984 | K841070 | CREATININE REAGENT SET Medical Specialties, Inc. | JFY |
| May 1, 1984 | K841069 | SERUM TOTAL PROTEIN REAGENT SET Medical Specialties, Inc. | CEK |
| May 1, 1984 | K841068 | UREA NITROGEN REAGENT SET Medical Specialties, Inc. | CDW |
| May 1, 1984 | K841067 | URIC ACID REAGENT SET Medical Specialties, Inc. | CDH |
| May 1, 1984 | K841066 | SGOT-UV REAGENT SET Medical Specialties, Inc. | CIT |
| May 1, 1984 | K841065 | SGOT REAGENT SET Medical Specialties, Inc. | CIQ |
| May 1, 1984 | K841064 | ALKALINE PHOSPHOTASE REAGENT SET Medical Specialties, Inc. | CIO |
| May 1, 1984 | K841063 | ALBUMIN REAGENT SET Medical Specialties, Inc. | CIX |
| May 1, 1984 | K841062 | TRIGLYCERIDE REAGENT SET Medical Specialties, Inc. | CDT |
| May 1, 1984 | K841061 | PHOPHORUS REAGNET SET Medical Specialties, Inc. | CEO |
| May 1, 1984 | K841060 | SGPT REAGENT SET Medical Specialties, Inc. | CKA |
| May 1, 1984 | K841059 | SGPT REAGENT SET Medical Specialties, Inc. | CKD |
| May 1, 1984 | K841058 | LDH-UV REAGENT SET Medical Specialties, Inc. | CFJ |
| May 1, 1984 | K841056 | HDL PRECIPITANT REAGENT SET Medical Specialties, Inc. | JHM |
| May 1, 1984 | K841055 | GLUCOSE ENZYMATIC REAGENT SET Medical Specialties, Inc. | CGA |
| May 1, 1984 | K841054 | DIRECT GLUCOSE REAGENT SET Medical Specialties, Inc. | CGE |
| May 1, 1984 | K841053 | CHOLESTEROL REAGENT SET ENZYMATIC Medical Specialties, Inc. | CHH |
| May 1, 1984 | K841052 | CHOLESTEROL REAGENT SET Medical Specialties, Inc. | CHD |
| May 1, 1984 | K841051 | SERUM CALCIUM REAGENT SET Medical Specialties, Inc. | CIC |
| May 1, 1984 | K841050 | TOTAL BILIRUBIN REAGENT SET Medical Specialties, Inc. | CIG |
| May 1, 1984 | K841049 | URIC ACID REAGENT SET ENZYMATIC Medical Specialties, Inc. | KNK |
| Mar 23, 1984 | K841057 | HEMOGLOBIN REAGENT SET Medical Specialties, Inc. | GKR |
| Jan 3, 1984 | K834043 | MSI-HC HEMATOLOGY CONTROL Medical Specialties, Inc. | JPK |
| Jul 18, 1983 | K831300 | MSI-NAK-50 TEST KIT Medical Specialties, Inc. | JGM |
| Sep 24, 1979 | K791831 | PROCAST Medical Specialties, Inc. | ITG |
| Aug 3, 1979 | K791363 | KWIK-AWA VEST Medical Specialties, Inc. | DRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||