CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN— 510(k) K792339
Substantially EquivalentConnecticut Diagnostics, Ltd.
FDA 510(k) clearance K792339 for CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN, Substantially Equivalent on 1979-12-06. Applicant: Connecticut Diagnostics, Ltd.. Device class: 2.
Clearance details
- Applicant
- Connecticut Diagnostics, Ltd.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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