FLUORESCEIN CONJUG. FRACT. MONO. ANTI.
FDA 510(k) clearance K772345 · decided 1978-01-05
Clearance details
- K-number
- K772345
- Device name
- FLUORESCEIN CONJUG. FRACT. MONO. ANTI.
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-23
- Decision date
- 1978-01-05
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- DCB
- Device class
- 1
- Regulation number
- 866.5520
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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.