AUTOFLUOR IV SYSTEM
FDA 510(k) clearance K843181 · decided 1984-09-17
Clearance details
- K-number
- K843181
- Device name
- AUTOFLUOR IV SYSTEM
- Applicant
- Tech America Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1984-08-13
- Decision date
- 1984-09-17
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- DBM
- Device class
- 2
- Regulation number
- 866.5090
- 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.