THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM— 510(k) K984181
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K984181 for THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM, Substantially Equivalent on 1999-01-22. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code LFY
- Device class
- Class 2
- Regulation
- 21 CFR 866.3900
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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