FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LATEX R. TYPHI
K Number: K860557
·
Decision Apr 21, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
3
Review Days
66
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Basic Information
- Device Name
- LATEX R. TYPHI
- K Number
- K860557
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3500
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Health Research, Inc.
- Date Received
- February 14, 1986
- Decision Date
- April 21, 1986
- Product Code
- GPM
- 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 |
|---|---|---|---|
| GPM | Antiserum, Murine Typhus Fever | FDA class 1 | Microbiology |