FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LATEX-R RICKETTSII
K Number: K843794
·
Decision Jan 4, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
3
Review Days
99
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Basic Information
- Device Name
- LATEX-R RICKETTSII
- K Number
- K843794
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3500
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Health Research, Inc.
- Date Received
- September 27, 1984
- Decision Date
- January 4, 1985
- Product Code
- GPP
- 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 |
|---|---|---|---|
| GPP | Antiserum, Rocky Mountain Spotted Fever | FDA class 1 | Microbiology |