ACS TOTAL IGE IMMUNOASSAY— 510(k) K920372
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K920372 for ACS TOTAL IGE IMMUNOASSAY, Substantially Equivalent on 1992-04-08. Applicant: Ciba Corning Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Walpole, MA, US
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