Pro-Lab Diagnostics
Georgetown, TX, US
PRO-LAB DIAGNOSTICS appears in FDA device records in Georgetown, TX. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Pro-Lab Diagnostics between 1992 and 1994. The busiest year on record is 1992, with 4. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 4 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K944421 | E.COLI 0157 LATEX TEST | GMZ | Substantially Equivalent | |
| K924331 | TRANSYSTEM LIQUID STUART MEDIUM | LIO | Substantially Equivalent | |
| K924330 | TRANSYSTEM AMIES WITH CHARCOAL | LIO | Substantially Equivalent | |
| K924329 | TRANSYSTEM AMIES W/O CHARCOAL | LIO | Substantially Equivalent | |
| K924328 | TRANSYSTEM LIQUID AMIES MEDIUM | LIO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1318862 | 1318862 | PRO-LAB DIAGNOSTICS | 1301 BLUE RIDGE DR, Georgetown, TX 78626 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
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