ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2— 510(k) K220801
Substantially EquivalentAbbott Diagnostics Scarborough, Inc.
FDA 510(k) clearance K220801 for ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2, Substantially Equivalent on 2022-06-24. Applicant: Abbott Diagnostics Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Product code
- Code OZE
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scarborough, ME, US
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More clearances from Abbott Diagnostics Scarborough, Inc.
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