WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY
FDA 510(k) clearance K880544 · decided 1988-04-01
Clearance details
- K-number
- K880544
- Device name
- WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY
- Applicant
- Wescor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-02-09
- Decision date
- 1988-04-01
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- GJL
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Logan, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.