CYTO-STAIN
FDA 510(k) clearance K830625 · decided 1983-03-24
Clearance details
- K-number
- K830625
- Device name
- CYTO-STAIN
- Applicant
- Richard-Allan Medical Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-01
- Decision date
- 1983-03-24
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- HJQ
- Device class
- 1
- Regulation number
- 886.1870
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.