FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TILL-U-TEST, DIP SLIDE
K Number: K780803
·
Decision Jun 6, 1978
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
43
Applicant Total
5
Review Days
26
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Basic Information
- Device Name
- TILL-U-TEST, DIP SLIDE
- K Number
- K780803
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biotron , Ltd.
- Date Received
- May 11, 1978
- Decision Date
- June 6, 1978
- Product Code
- JXA
- 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 |
|---|---|---|---|
| JXA | Kit, Screening, Urine | FDA class 1 | Microbiology |
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