LEGIONELLA IGG/IGM ELISA TEST SYSTEM— 510(k) K963318
Substantially EquivalentArmkel, LLC
FDA 510(k) clearance K963318 for LEGIONELLA IGG/IGM ELISA TEST SYSTEM, Substantially Equivalent on 1997-03-03. Applicant: Armkel, LLC. Device class: 2.
Clearance details
- Applicant
- Armkel, LLC
- 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
- Frederick, MD, US
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More clearances from Armkel, LLC
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