FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Colibri System
K Number: K193138
·
Decision Dec 27, 2021
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
5
Review Days
775
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Basic Information
- Device Name
- Colibri System
- K Number
- K193138
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3378
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Copan Wasp Srl
- Date Received
- November 13, 2019
- Decision Date
- December 27, 2021
- Product Code
- QQV
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QQV | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | FDA class 2 | Microbiology |
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