DADE HEPZYME
FDA 510(k) clearance K925452 · decided 1993-01-11
Clearance details
- K-number
- K925452
- Device name
- DADE HEPZYME
- Applicant
- Baxter Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-28
- Decision date
- 1993-01-11
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- JBR
- Device class
- 2
- Regulation number
- 864.7525
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Miami, FL, 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 |
|---|---|---|
| PT PRO-CLOT (K874373) | Probe-Tek, Inc. | 1988-01-05 |
| THROMBO SCREEN QUANTITATIVE HEPARIN ASSA (K770722) | Bay Area Hema. Onco. Clinic. & Res. L | 1977-07-11 |
Recalls involving this device
No recalls on record reference this clearance.