TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))— 510(k) K875274
Substantially EquivalentIncstar Corp.
FDA 510(k) clearance K875274 for TOTAL IGE IMMUNO RESPONSE TEST (IRT(R)), Substantially Equivalent on 1988-02-17. Applicant: Incstar Corp.. Device class: 2.
Clearance details
- Applicant
- Incstar Corp.
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stillwater, MN, US
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