FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT
K Number: K882674
·
Decision Aug 15, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
7
Applicant Total
2
Review Days
413
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Basic Information
- Device Name
- IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT
- K Number
- K882674
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Icn Immunobiologicals
- Date Received
- June 28, 1988
- Decision Date
- August 15, 1989
- Product Code
- LKH
- 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 |
|---|---|---|---|
| LKH | Antisera, Immunoperoxidase, Chlamydia Spp. | FDA class 1 | Microbiology |
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Other Clearances by Icn Immunobiologicals
| K Number | Device Name | ||
|---|---|---|---|
| K882369 | ACCRAASSAY RID KITS | Jul 12, 1988 | Substantially Equivalent |