FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHYTOHAEMAGGLUTININ
K Number: K790239
·
Decision Mar 8, 1979
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
0
Applicant Total
1
Review Days
35
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Basic Information
- Device Name
- PHYTOHAEMAGGLUTININ
- K Number
- K790239
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2260
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia Fine Chemicals
- Date Received
- February 1, 1979
- Decision Date
- March 8, 1979
- Product Code
- KIQ
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KIQ | Kit, Culture, Chromosome | FDA class 1 | Hematology |