SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
FDA 510(k) clearance K042459 · decided 2004-11-17
Clearance details
- K-number
- K042459
- Device name
- SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-10
- Decision date
- 2004-11-17
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Brea, CA, 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.
Recalls involving this device
No recalls on record reference this clearance.
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|---|---|---|
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| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |