ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)— 510(k) K042307
Substantially EquivalentSeradyn, Inc.
FDA 510(k) clearance K042307 for ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH), Substantially Equivalent on 2004-11-03. Applicant: Seradyn, Inc.. Device class: 2.
Clearance details
- Applicant
- Seradyn, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Indianapolis, IN, US
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