POLYSTAT, BIOLOGICAL STAIN
FDA 510(k) clearance K844640 · decided 1985-01-30
Clearance details
- K-number
- K844640
- Device name
- POLYSTAT, BIOLOGICAL STAIN
- Applicant
- Surgipath Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-28
- Decision date
- 1985-01-30
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- IAB
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Grayslake, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.