FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
#4005 TSA SLANT-TUBED MEDIA
K Number: K820791
·
Decision Apr 8, 1982
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
208
Applicant Total
19
Review Days
16
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Basic Information
- Device Name
- #4005 TSA SLANT-TUBED MEDIA
- K Number
- K820791
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biomedica, Inc.
- Date Received
- March 23, 1982
- Decision Date
- April 8, 1982
- Product Code
- JSG
- 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | FDA class 1 | Microbiology |
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