THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC— 510(k) K983426
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K983426 for THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC, Substantially Equivalent on 1998-11-18. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code LLL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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