NEEDLE COUNTER-SURE COUNT/100 COUNT— 510(k) K801259
Substantially EquivalentKleen Test Products
FDA 510(k) clearance K801259 for NEEDLE COUNTER-SURE COUNT/100 COUNT, Substantially Equivalent on 1980-06-09. Applicant: Kleen Test Products. Device class: 2.
Clearance details
- Applicant
- Kleen Test Products
- Product code
- Code MMK
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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