IMAGEN RESPIRATORY SCREEN— 510(k) K973954
Substantially EquivalentDako Diagnostics , Ltd.
FDA 510(k) clearance K973954 for IMAGEN RESPIRATORY SCREEN, Substantially Equivalent on 1997-12-22. Applicant: Dako Diagnostics , Ltd.. Device class: 1.
Clearance details
- Applicant
- Dako Diagnostics , Ltd.
- Product code
- Code GNW
- Device class
- Class 1
- Regulation
- 21 CFR 866.3330
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridgeshire, GB
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More clearances from Dako Diagnostics , Ltd.
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