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.
Clearance details
- Applicant
- Armkel, LLC
- Product code
- Code LHL
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Frederick, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.