AUTOIMMUNE TEST 1/2/3 SYSTEM— 510(k) K833119
Substantially EquivalentAtlantic Antibodies
FDA 510(k) clearance K833119 for AUTOIMMUNE TEST 1/2/3 SYSTEM, Substantially Equivalent on 1983-11-21. Applicant: Atlantic Antibodies. Device class: 2.
Clearance details
- Applicant
- Atlantic Antibodies
- Product code
- Code DHN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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