STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
FDA 510(k) clearance K933464 · decided 1993-10-22
Clearance details
- K-number
- K933464
- Device name
- STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
- Applicant
- Baxter Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-16
- Decision date
- 1993-10-22
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- CHP
- Device class
- 1
- Regulation number
- 862.1260
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mcgaw Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.