AUTOANTIBODY SCREEN TEST SYSTEM— 510(k) K831358
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K831358 for AUTOANTIBODY SCREEN TEST SYSTEM, Substantially Equivalent on 1983-06-15. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code DBM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5090
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.