THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE— 510(k) K983803
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K983803 for THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE, Substantially Equivalent on 1998-12-14. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code LFZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.