ATYPICAL CHOLINESTERASE
FDA 510(k) clearance K873496 · decided 1989-01-27
Clearance details
- K-number
- K873496
- Device name
- ATYPICAL CHOLINESTERASE
- Applicant
- Sclavo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-18
- Decision date
- 1989-01-27
- Days to decision
- 528 days
- Clearance type
- Traditional
- Product code
- DIH
- Device class
- 1
- Regulation number
- 862.3240
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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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 |
| CHOLINESTERASE GEN.2 TEST SYSTEM (K061093) | Roche Diagnostics Corp. | 2006-07-03 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.