FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
K Number: K872082
·
Decision Jul 31, 1987
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
22
Applicant Total
57
Review Days
63
Basic Information
- Device Name
- RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
- K Number
- K872082
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3480
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
- Date Received
- May 29, 1987
- Decision Date
- July 31, 1987
- Product Code
- LKT
- 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 |
|---|---|---|---|
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | FDA class 1 | Microbiology |
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