MODIFICATION TO: INSTAREAD LITHIUM SYSTEM— 510(k) K050338
Substantially EquivalentAkers Biosciences, Inc.
FDA 510(k) clearance K050338 for MODIFICATION TO: INSTAREAD LITHIUM SYSTEM, Substantially Equivalent on 2005-03-04. Applicant: Akers Biosciences, Inc..
Clearance details
- Applicant
- Akers Biosciences, Inc.
- Product code
- Code JIH
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Thorofare, NJ, US
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