FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST
K Number: K901243
·
Decision May 21, 1990
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
34
Applicant Total
1
Review Days
67
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Basic Information
- Device Name
- CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST
- K Number
- K901243
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Cel Labs Pty, Ltd.
- Date Received
- March 15, 1990
- Decision Date
- May 21, 1990
- 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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