KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
FDA 510(k) clearance K042248 · decided 2004-12-17
Clearance details
- K-number
- K042248
- Device name
- KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
- Applicant
- Kronus Market Development Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-19
- Decision date
- 2004-12-17
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- NST
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Boise, ID, 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 |
|---|---|---|
| IVD TECHNOLOGIES ACHRAB TEST KIT (K091468) | Ivd Technologies | 2009-11-20 |
| KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT (K080523) | Kronus Market Development Associates, Inc. | 2008-06-17 |
| ACETYLCHOLINE RECEPTOR AB (ARAB)RRA (K051144) | Ibl-Hamburg GmbH | 2005-11-18 |
Recalls involving this device
No recalls on record reference this clearance.