DIRECT FA CONJUGATE FOR LEGIONELLA SP— 510(k) K813339
Substantially EquivalentSpringwood Microbiologicals
FDA 510(k) clearance K813339 for DIRECT FA CONJUGATE FOR LEGIONELLA SP, Substantially Equivalent on 1981-12-18. Applicant: Springwood Microbiologicals. Device class: 2.
Clearance details
- Applicant
- Springwood Microbiologicals
- Product code
- Code LHL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3300
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Springwood Microbiologicals
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