APO B RIA KIT— 510(k) K851389
Substantially EquivalentIso-Tex Diagnostics
FDA 510(k) clearance K851389 for APO B RIA KIT, Substantially Equivalent on 1985-07-10. Applicant: Iso-Tex Diagnostics. Device class: 1.
Clearance details
- Applicant
- Iso-Tex Diagnostics
- Product code
- Code MSJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Friendswood, TX, US
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More clearances from Iso-Tex Diagnostics
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