ACCUDATA GLUCOSE TEST STATION
FDA 510(k) clearance K924475 · decided 1992-10-13
Clearance details
- K-number
- K924475
- Device name
- ACCUDATA GLUCOSE TEST STATION
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-03
- Decision date
- 1992-10-13
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS recall (Z-1366-06) | Roche Diagnostics Corp. | 2006-08-05 |
| AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data Management, recall (Z-1367-06) | Roche Diagnostics Corp. | 2006-08-05 |
| GTS Advantage Meter. Cat. no. 424. Ref. no. 03144780001 with meter model no. 777. recall (Z-1368-06) | Roche Diagnostics Corp. | 2006-08-05 |
| Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001. recall (Z-0881-05) | Roche Diagnostics Corp. | 2005-06-11 |
| Roche brand AccuData GTS System; Catalog number 404, material number 03136833001. recall (Z-0882-05) | Roche Diagnostics Corp. | 2005-06-11 |
| Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, recall (Z-0883-05) | Roche Diagnostics Corp. | 2005-06-11 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |