FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHLAMYDIAZYME DIAGNOSTIC KIT
K Number: K864842
·
Decision Apr 29, 1987
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
66
Applicant Total
883
Review Days
140
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Basic Information
- Device Name
- CHLAMYDIAZYME DIAGNOSTIC KIT
- K Number
- K864842
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- December 10, 1986
- Decision Date
- April 29, 1987
- 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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