FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT
K Number: K862354
·
Decision Sep 29, 1986
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
34
Applicant Total
3
Review Days
101
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Basic Information
- Device Name
- MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT
- K Number
- K862354
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Synbiotics Corp.
- Date Received
- June 20, 1986
- Decision Date
- September 29, 1986
- Product Code
- LJP
- 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 |
|---|---|---|---|
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | FDA class 1 | Microbiology |
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