Dey Laboratories, Inc.
Mchenry, IL, US
Dey Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 6 510(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
- 6
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 6 510(k) clearances for Dey Laboratories, Inc. between 1983 and 1997. The busiest year on record is 1988, with 3. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1988 | 3 |
| 1991 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972778 | DEY VIAL SODIUM CHLORIDE 3% | CAF | Substantially Equivalent | |
| K910239 | NEBU-SOL METERED DOSE DISPENSER (TM) | BSY | Substantially Equivalent | |
| K880411 | DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE | CAF | Substantially Equivalent | |
| K875024 | DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP | CCQ | Substantially Equivalent | |
| K875011 | DEY-PAK PURIFIED WATER, USP, STERILE | CCQ | Substantially Equivalent | |
| K831532 | OCULAR IRRIGATING CANNULA | HMX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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