THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.— 510(k) K993250
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K993250 for THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM., Substantially Equivalent on 1999-11-12. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code MST
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.