FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Great Basin Staph ID/R Blood Culture Panel
K Number: K152470
·
Decision Mar 25, 2016
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
4
Review Days
207
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Basic Information
- Device Name
- Great Basin Staph ID/R Blood Culture Panel
- K Number
- K152470
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3365
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Great Basin Scientific, Inc.
- Date Received
- August 31, 2015
- Decision Date
- March 25, 2016
- Product Code
- PAM
- 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 |
|---|---|---|---|
| PAM | Gram-Positive Bacteria And Their Resistance Markers | FDA class 2 | Microbiology |
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