Home Diagnostics, Inc.
Fort Lauderdale, FL, US
Home Diagnostics, Inc. appears in FDA device records in Fort Lauderdale, FL. FDA records list 22 510(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
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Home Diagnostics, Inc. between 1985 and 2009. The busiest year on record is 2004, with 3. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 1 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 2 |
| 1996 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090495 | TRUEBALANCE BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | |
| K080641 | TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 | NBW | Substantially Equivalent | |
| K080710 | TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 | NBW | Substantially Equivalent | |
| K070593 | TRACKRECORD DATA MANAGEMENT SOFTWARE | NBW | Substantially Equivalent | |
| K060793 | ELEMENT BLOOD GLUCOSE TEST SYSTEM | NBW | Substantially Equivalent | |
| K051147 | SIDEKICK BLOOD GLUCOSE TEST SYSTEM | NBW | Substantially Equivalent | |
| K042080 | TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM | JJX | Substantially Equivalent | |
| K040670 | MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL | NBW | Substantially Equivalent | |
| K032657 | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) | NBW | Substantially Equivalent | |
| K030703 | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS | NBW | Substantially Equivalent | |
| K010403 | PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 | NBW | Substantially Equivalent | |
| K992988 | PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM | CGA | Substantially Equivalent | |
| K960855 | PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL | CGA | Substantially Equivalent | |
| K922137 | DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP | CGA | Substantially Equivalent | |
| K922136 | ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP | CGA | Substantially Equivalent | |
| K915772 | DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP | CGA | Substantially Equivalent | |
| K915770 | ULTRA+ BLOOD GLUCOSE TEST STRIP | CGA | Substantially Equivalent | |
| K912440 | ULTRA BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K872505 | DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS | CGA | Substantially Equivalent | |
| K861265 | DIALET LANCING DEVICE | FMK | Substantially Equivalent | |
| K853553 | DIASCAN CONTROL | JJX | Substantially Equivalent | |
| K851618 | DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS | CGA | 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
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Is this your company?
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Data as of , FDA export datePage updated Source: openFDA, public domain