FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
K Number: K895468
·
Decision Mar 13, 1990
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
66
Applicant Total
3
Review Days
183
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Basic Information
- Device Name
- ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
- K Number
- K895468
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Orgenics, Ltd.
- Date Received
- September 11, 1989
- Decision Date
- March 13, 1990
- Product Code
- LJC
- 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 |
|---|---|---|---|
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | FDA class 1 | Microbiology |
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