FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)
K Number: K962745
·
Decision Oct 2, 1996
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
12
Applicant Total
3
Review Days
79
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Basic Information
- Device Name
- ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)
- K Number
- K962745
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Prepared Media Laboratory, Inc.
- Date Received
- July 15, 1996
- Decision Date
- October 2, 1996
- Product Code
- JSN
- 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 |
|---|---|---|---|
| JSN | Culture Media, Propagating Transport | FDA class 1 | Microbiology |
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