Meretek Diagnostics, Inc.
Nashville, TN, US
Meretek Diagnostics, Inc. appears in FDA device records in Nashville, TN. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Meretek Diagnostics, Inc. between 1996 and 2002. The busiest year on record is 1996, with 1. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K014225 | BREATHTEK - UBIT UBT FOR H. PYLORI | MSQ | Substantially Equivalent | |
| K972352 | THE MERETEK UBT BREATH TEST FOR H.PYLORI | MSQ | Substantially Equivalent | |
| K952220 | MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT | LYR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0003-2008 | BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO. | Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain