FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

HERPES VIRUS AGGLUTINATION TEST

K Number: K842887 · Decision Feb 26, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
15
Applicant Total
5
Review Days
218

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Basic Information

Device Name
HERPES VIRUS AGGLUTINATION TEST
K Number
K842887
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
866.3305
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
Scientific Research
Date Received
July 23, 1984
Decision Date
February 26, 1985
Product Code
GQO
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
GQO Antisera, Cf, Herpesvirus Hominis 1,2

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (GQO), ordered by most recent decision date.

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Other Clearances by Scientific Research

K Number Device Name
K912420 ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM
K843077 ELISA FOR HERPES SIMPLEX VIRUS
K843369 AGGLUTINATION TEST FOR TOTAL IGE
K843710 ELISA FOR TOTAL IGE