QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)— 510(k) K973464
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K973464 for QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL), Substantially Equivalent on 1997-10-22. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code DHR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Recent devices under product code DHR
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