RAPID ACID FAST STAIN
FDA 510(k) clearance K864033 · decided 1986-11-13
Clearance details
- K-number
- K864033
- Device name
- RAPID ACID FAST STAIN
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-15
- Decision date
- 1986-11-13
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- KJY
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.