AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
FDA 510(k) clearance K964406 · decided 1997-09-25
Clearance details
- K-number
- K964406
- Device name
- AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
- Applicant
- Daxor Corporation
- Decision
- Substantially Equivalent
- Date received
- 1996-11-04
- Decision date
- 1997-09-25
- Days to decision
- 325 days
- Clearance type
- Traditional
- Product code
- JWO
- Device class
- 2
- Regulation number
- 864.5950
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- New York, NY, 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 |
|---|---|---|
| Blood Volume Analyzer (200) (K261099) | Daxor Corporation | 2026-06-18 |
| Blood Volume Analyzer (200) (K251087) | Daxor Corporation | 2025-08-04 |
Recalls involving this device
No recalls on record reference this clearance.