FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
B-STREP-TECT-II
K Number: K840160
·
Decision Mar 2, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
3
Review Days
49
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Basic Information
- Device Name
- B-STREP-TECT-II
- K Number
- K840160
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Uti-Tect, Inc.
- Date Received
- January 13, 1984
- Decision Date
- March 2, 1984
- Product Code
- JSI
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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