FDA PMA FDA Class 2 Approved 🇺🇸 United States

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

PMA: N50525 · Supplement: S001 · Decision Jan 10, 1980
Classifications
1
FEI Numbers
23
Registration Numbers
23

Basic Information

Device Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Trade Name
MS 2 MICROBIAL SYSTEM
PMA Number
N50525
Supplement Number
S001
Device Class
FDA Class 2
Product Code
LON
Generic Name
SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number
866.1645
Medical Specialty
Microbiology
Advisory Committee
Microbiology
Decision
Approved
Decision Code
APPR
Decision Date
January 10, 1980
Date Received
July 16, 1979
Expedited Review
N

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation