SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
FDA 510(k) clearance K993022 · decided 1999-11-09
Clearance details
- K-number
- K993022
- Device name
- SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-09
- Decision date
- 1999-11-09
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- DLJ
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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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 |