ELECSYS 2010 ANALYZER
FDA 510(k) clearance K961481 · decided 1996-06-14
Clearance details
- K-number
- K961481
- Device name
- ELECSYS 2010 ANALYZER
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-18
- Decision date
- 1996-06-14
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- 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 |
|---|---|---|
| Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-0 recall (Z-1790-2014) | Roche Diagnostics Operations, Inc. | 2014-06-14 |
| Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the recall (Z-1218-2012) | Roche Diagnostics Operations, Inc. | 2012-03-16 |
| Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos recall (Z-0165-2009) | Roche Diagnostics Corp. | 2008-10-22 |
| Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalo recall (Z-0868-2008) | Roche Diagnostics Corp. | 2008-08-13 |
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 |