Company ยท US
Derma Media Lab., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 1997. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JGY | Colorimetric Method, Triglycerides | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 1997 | K971309 | UREA Derma Media Lab., Inc. | CDQ |
| Aug 1, 1997 | K970664 | GLUCOSE REAGENT Derma Media Lab., Inc. | CFR |
| Jun 20, 1997 | K971072 | CHOLESTEROL REAGENT Derma Media Lab., Inc. | CHH |
| Apr 21, 1997 | K971005 | TRIGLYCERIDES Derma Media Lab., Inc. | JGY |
| Apr 21, 1997 | K970867 | URIC ACID REAGENT Derma Media Lab., Inc. | KNK |
| Mar 26, 1997 | K964915 | MAGNESIUM Derma Media Lab., Inc. | JGJ |
| Feb 20, 1997 | K964913 | IRON REAGENT Derma Media Lab., Inc. | JIY |
| Feb 18, 1997 | K965134 | ALT/SGPT Derma Media Lab., Inc. | CKA |
| Feb 4, 1997 | K964914 | ALKALINE PHOSPHATASE Derma Media Lab., Inc. | CJE |
| Jan 17, 1997 | K965126 | AST/SGOT Derma Media Lab., Inc. | CIT |
| Jan 10, 1997 | K964916 | GAMMA-GLUTAMYL TRANSPEPTIDASE Derma Media Lab., Inc. | JQB |
| Jan 9, 1997 | K964912 | LACTATE DEHYDROGENASE Derma Media Lab., Inc. | CFJ |
| Mar 13, 1996 | K955940 | TOTAL BILIRUBIN REAGENT Derma Media Lab., Inc. | CIG |
| Mar 13, 1996 | K955939 | CALCIUM REAGENT Derma Media Lab., Inc. | CIC |
| Mar 13, 1996 | K955781 | ALBUMIN Derma Media Lab., Inc. | CIX |
| Mar 12, 1996 | K955938 | CREATININE REAGENT Derma Media Lab., Inc. | CGX |
| Mar 12, 1996 | K955937 | INORGANIC PHOSPHORUS REAGENT Derma Media Lab., Inc. | CEO |
| Mar 12, 1996 | K955936 | TOTAL PROTEIN REAGENT Derma Media Lab., Inc. | CEK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||