IL TEST IGG IGA & IGM KITS
FDA 510(k) clearance K833841 · decided 1984-01-04
Clearance details
- K-number
- K833841
- Device name
- IL TEST IGG IGA & IGM KITS
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1983-11-07
- Decision date
- 1984-01-04
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- CZK
- Device class
- 2
- Regulation number
- 866.5510
- 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.