FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUPUS(LE)-LATEX TEST
K Number: K905531
·
Decision Jan 25, 1991
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
5
Applicant Total
55
Review Days
46
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Basic Information
- Device Name
- LUPUS(LE)-LATEX TEST
- K Number
- K905531
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Immco Diagnostics, Inc.
- Date Received
- December 10, 1990
- Decision Date
- January 25, 1991
- Product Code
- LKI
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LKI | Antisera, Fluorescent, Chlamydia Spp. | FDA class 1 | Microbiology |
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