FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
chromID Strepto B agar
K Number: K163042
·
Decision Jan 27, 2017
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
251
Review Days
88
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Basic Information
- Device Name
- chromID Strepto B agar
- K Number
- K163042
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- bioMerieux, Inc.
- Date Received
- October 31, 2016
- Decision Date
- January 27, 2017
- Product Code
- PQZ
- 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 |
|---|---|---|---|
| PQZ | Gbs Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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