FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LATEX R. CONORII
K Number: K872129
·
Decision Aug 19, 1987
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
3
Applicant Total
3
Review Days
78
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Basic Information
- Device Name
- LATEX R. CONORII
- K Number
- K872129
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3500
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Health Research, Inc.
- Date Received
- June 2, 1987
- Decision Date
- August 19, 1987
- Product Code
- LSQ
- 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 |
|---|---|---|---|
| LSQ | Reagent, Rickettsia Serological | FDA class 1 | Microbiology |
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