Dilab, Inc.
Miami, FL, US
Dilab, Inc. appears in FDA device records in Miami, FL. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Dilab, Inc. between 1985 and 1987. The busiest year on record is 1985, with 10. The most recent is 1987, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 10 |
| 1987 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K862530 | RAPID AS LATEX | GTQ | Substantially Equivalent | |
| K850931 | ALBUMIN | CIX | Substantially Equivalent | |
| K850938 | CHOLESTEROL | CGO | Substantially Equivalent | |
| K850936 | TOTAL PROTEINS | CEK | Substantially Equivalent | |
| K850934 | PHOSPHORUS | CEO | Substantially Equivalent | |
| K850933 | URIC ACID | CDH | Substantially Equivalent | |
| K850932 | CREATININE | CGX | Substantially Equivalent | |
| K850937 | UREA | CDW | Substantially Equivalent | |
| K850935 | CHLORIDE | CHJ | Substantially Equivalent | |
| K850930 | GLUCOSE | CGE | Substantially Equivalent | |
| K850929 | CALCIUM | CIC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CDHAcid, Uric, Phosphotungstate Reduction
- CGXAlkaline Picrate, Colorimetry, Creatinine
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CICCresolphthalein Complexone, Calcium
- CDWDiacetyl-Monoxime, Urea Nitrogen
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CGEOrthotoluidine, Glucose
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain