MYOGLOBIN RIA TEST KIT— 510(k) K904038
Substantially EquivalentImmuno Diagnostic Center, Inc.
FDA 510(k) clearance K904038 for MYOGLOBIN RIA TEST KIT, Substantially Equivalent on 1990-09-24. Applicant: Immuno Diagnostic Center, Inc.. Device class: 2.
Clearance details
- Applicant
- Immuno Diagnostic Center, Inc.
- Product code
- Code DDR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Friendswood, TX, US
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