Chester Labs, Inc.
Cincinnati, OH, US
Chester Labs, Inc. appears in FDA device records in Cincinnati, OH. 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 Chester Labs, Inc. between 1985 and 2004. The busiest year on record is 1995, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1994 | 2 |
| 1995 | 3 |
| 1996 | 2 |
| 2000 | 2 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041060 | E-Z LUBRICATING JELLY | KMJ | Substantially Equivalent | |
| K001705 | STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF | GYB | Substantially Equivalent | |
| K001593 | MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL | GEI | Substantially Equivalent | |
| K944599 | GRAHAM-FIELD CONDUCTIVE ECG SPRAY | GYB | Substantially Equivalent | |
| K944598 | GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL | GYB | Substantially Equivalent | |
| K944600 | GRAHAM-FIELD SALINE ELECTROLYTE GEL | GYB | Substantially Equivalent | |
| K944597 | GRAHAM-FIELD ULTRASOUND SCANNING GEL | IYO | Substantially Equivalent | |
| K944596 | GRAHAM-FIELD ULTRASOUND LOTION | IMI | Substantially Equivalent | |
| K940256 | BIOSHIELD BLUE LATEX GLOVES | LYY | Substantially Equivalent | |
| K940254 | BIOSHIELD BLUE POWDER FREE GLOVE | LYY | Substantially Equivalent | |
| K841871 | LIQUA-SONIC GEL | GYB | 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