CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES— 510(k) K850256
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K850256 for CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES, Substantially Equivalent on 1985-04-08. Applicant: Abbott Laboratories. Device class: 1.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code GTZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abbott Park, IL, US
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More clearances from Abbott Laboratories
view allData sourced from openFDA. This site is unofficial and independent of the FDA.