RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT— 510(k) K852185
Substantially EquivalentBartels Immunodiagnostic Supplies, Inc.
FDA 510(k) clearance K852185 for RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT, Substantially Equivalent on 1985-08-19. Applicant: Bartels Immunodiagnostic Supplies, Inc.. Device class: 1.
Clearance details
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
- Product code
- Code LKT
- Device class
- Class 1
- Regulation
- 21 CFR 866.3480
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellevue, WA, US
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