LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY— 510(k) K921421
Substantially EquivalentPro-Lab, Inc.
FDA 510(k) clearance K921421 for LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY, Substantially Equivalent on 1992-07-28. Applicant: Pro-Lab, Inc.. Device class: 2.
Clearance details
- Applicant
- Pro-Lab, Inc.
- 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
- Ontario Canada M5m 1c9, CA
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