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
KIQ Kit, Culture, Chromosome