CHOLINESTERASE GEN.2 TEST SYSTEM
FDA 510(k) clearance K061093 · decided 2006-07-03
Clearance details
- K-number
- K061093
- Device name
- CHOLINESTERASE GEN.2 TEST SYSTEM
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-19
- Decision date
- 2006-07-03
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- DIH
- Device class
- 1
- Regulation number
- 862.3240
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Roche Diagnostics Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 (K103373) | Beckman Coulter, Inc. | 2011-02-07 |
| SENTINEL CHOLINESTERASE LIQUID (K051444) | Sentinel Ch. Srl | 2005-06-20 |
| OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) (K030045) | Olympus America, Inc. | 2003-02-21 |
| WIENER LAB COLINESTERASA AA (K023992) | Wiener Laboratories Saic | 2003-02-12 |
| ADVIA 1650 CHOLINESTERASE ASSAY (K013750) | Bayer Diagnostics Corp. | 2002-01-18 |
| CARESIDE CHOLINESTERASE (K002792) | Careside, Inc. | 2000-11-08 |
| ADVIA IMS (K001344) | Bayer Corp. | 2000-06-26 |
| TEST-MATE CHE CHOLINESTERASE TEST SYSTEM (K961656) | Eqm Research, Inc. | 1996-11-26 |
| IL TEST CHOLINESTERASE (K943367) | Instrumentation Laboratory CO | 1996-02-05 |
| CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 (K955498) | Diagnostic Chemicals , Ltd. | 1996-01-24 |
| IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE (K914171) | Tech Intl. Co. | 1991-12-18 |
| KODAK EKTACHEM DT SLIDES (CHE) (K913198) | Eastman Kodak Company | 1991-08-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110022/S034) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBs (P010054/S048) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |