FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
K Number: K181711
·
Decision Aug 15, 2018
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
30
Applicant Total
18
Review Days
48
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Basic Information
- Device Name
- BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
- K Number
- K181711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3920
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microbiologics, Inc.
- Date Received
- June 28, 2018
- Decision Date
- August 15, 2018
- Product Code
- PMN
- 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 |
|---|---|---|---|
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | FDA class 2 | Microbiology |
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