Company ยท US
Dilab, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1987. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CGE | Orthotoluidine, Glucose | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 1987 | K862530 | RAPID AS LATEX Dilab, Inc. | GTQ |
| Jun 26, 1985 | K850931 | ALBUMIN Dilab, Inc. | CIX |
| Jun 25, 1985 | K850938 | CHOLESTEROL Dilab, Inc. | CGO |
| Jun 25, 1985 | K850936 | TOTAL PROTEINS Dilab, Inc. | CEK |
| Jun 25, 1985 | K850934 | PHOSPHORUS Dilab, Inc. | CEO |
| Jun 25, 1985 | K850933 | URIC ACID Dilab, Inc. | CDH |
| Jun 25, 1985 | K850932 | CREATININE Dilab, Inc. | CGX |
| Jun 10, 1985 | K850937 | UREA Dilab, Inc. | CDW |
| Jun 10, 1985 | K850935 | CHLORIDE Dilab, Inc. | CHJ |
| Jun 10, 1985 | K850930 | GLUCOSE Dilab, Inc. | CGE |
| Jun 10, 1985 | K850929 | CALCIUM Dilab, Inc. | CIC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||