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Miscellaneous
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
2
Product Code
JTN
Susceptibility Test Discs, Antimicrobial
2
Product Code
JTT
Susceptibility Test Powders, Antimicrobial
2
Product Code
K
98
3310
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
2
Cleared 510(K)
K
93
5805
PASCO MIC AND MIC/ID PANELS
2
Cleared 510(K)
K
89
5362
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
2
Cleared 510(K)
K
88
0574
MODIFIED IMIPENEM SUSCEPTIBILITY POWDER
2
Cleared 510(K)
K
87
2081
CIPRO (TM) DIAGNOSTIC POWDER
2
Cleared 510(K)
K
86
4442
NORFLOXACIN SUSCEPTIBILITY POWDER
2
Cleared 510(K)
K
86
0031
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
2
Cleared 510(K)
K
85
5207
IMIPENEM 10 MCG SENSITIVITY DISCS
2
Cleared 510(K)
K
85
5106
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
2
Cleared 510(K)
K
85
5071
IMIPENEM SUSCEPTIBILITY POWDER
2
Cleared 510(K)
K
83
0758
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
2
Cleared 510(K)
K
82
2866
MOXALACTAM
2
Cleared 510(K)
K
82
2329
ANTITUBERCULOUS DRUGS (SIRE)
2
Cleared 510(K)
K
82
0578
MEZLIN DIAGNOSTIC REAGENT
2
Cleared 510(K)
N
50
407
STERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE
2
PMA Approval
N
50
413
GEOPEN SUSCEPTIBILITY POWDER
2
PMA Approval
N
50
163
STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN)
2
PMA Approval
N
50
042
POTASSIUM PENICILLIN G DIAG SYS POWDER
2
PMA Approval
N
50
009
TERRAMYCIN DIAGNOSTIC SUSCEPTIBILITY POWDER
2
PMA Approval
N
50
062
OLEANDOMYCIN PHOSPHATE SUSCEPTIBILITY POWDER
2
PMA Approval
N
50
036
STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW
2
PMA Approval
N
50
016
BACITRACIN DIAGNOSTIC SUSCEPTIBILITY POWDER
2
PMA Approval
N
50
100
VIBRAMYCIN DIAG. SUSCEPTIBILITY POWDER (DOXYCYCLIN
2
PMA Approval
N
61
034
LINCOCIN SUSCEPTIBILITY PWD
2
PMA Approval
JTZ
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
2
Product Code
JWY
Manual Antimicrobial Susceptibility Test Systems
2
Product Code
LIE
Reagent/Device, Inoculum Calibration
2
Product Code
LKA
Culture Media, Antimicrobial Susceptibility Test
2
Product Code
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
2
Product Code
LOP
Solution, Antimicrobial
2
Product Code
LRG
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
2
Product Code
LTT
Panels, Test, Susceptibility, Antimicrobial
2
Product Code
LTW
Susceptibility Test Cards, Antimicrobial
2
Product Code
LTX
Discs, Elution
2
Product Code
MJA
Susceptibility Test Powders, Antimycobacterial
2
Product Code
MJD
Culture Media, Antimycobacteria, Susceptibility Test
2
Product Code
MJE
Culture Media, Antifungal, Susceptibility Test
2
Product Code
MYI
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
2
Product Code
NGZ
Susceptibility Test Plate, Antifungal
2
Product Code
NIJ
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
2
Product Code
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
2
Product Code
PMY
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
2
Product Code
POC
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
2
Product Code
PRH
Positive Blood Culture Identification And Ast Kit
2
Product Code
PTJ
Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
2
Product Code
QIV
Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
2
Product Code
QZX
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
2
Product Code
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
2
Product Code
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
MI
/
subpart-b—diagnostic-devices
/
JTT
/
N50042
View Source
POTASSIUM PENICILLIN G DIAG SYS POWDER
Page Type
PMA Approval
Applicant
PFIZER, INC.
Trade Name
POTASSIUM PENICILLIN G DIAG SYS POWDER
Generic Name
Susceptibility test powders, antimicrobial
Decision Date
2/27/1970
Days to Decision
25624 days
Decision Code
APRL
FDA Decision
Reclassification after approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
JTN
Susceptibility Test Discs, Antimicrobial
JTT
Susceptibility Test Powders, Antimicrobial
K
98
3310
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
K
93
5805
PASCO MIC AND MIC/ID PANELS
K
89
5362
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
K
88
0574
MODIFIED IMIPENEM SUSCEPTIBILITY POWDER
K
87
2081
CIPRO (TM) DIAGNOSTIC POWDER
K
86
4442
NORFLOXACIN SUSCEPTIBILITY POWDER
K
86
0031
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
K
85
5207
IMIPENEM 10 MCG SENSITIVITY DISCS
K
85
5106
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
K
85
5071
IMIPENEM SUSCEPTIBILITY POWDER
K
83
0758
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
K
82
2866
MOXALACTAM
K
82
2329
ANTITUBERCULOUS DRUGS (SIRE)
K
82
0578
MEZLIN DIAGNOSTIC REAGENT
N
50
407
STERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE
N
50
413
GEOPEN SUSCEPTIBILITY POWDER
N
50
163
STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN)
N
50
042
POTASSIUM PENICILLIN G DIAG SYS POWDER
N
50
009
TERRAMYCIN DIAGNOSTIC SUSCEPTIBILITY POWDER
N
50
062
OLEANDOMYCIN PHOSPHATE SUSCEPTIBILITY POWDER
N
50
036
STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW
N
50
016
BACITRACIN DIAGNOSTIC SUSCEPTIBILITY POWDER
N
50
100
VIBRAMYCIN DIAG. SUSCEPTIBILITY POWDER (DOXYCYCLIN
N
61
034
LINCOCIN SUSCEPTIBILITY PWD
JTZ
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
JWY
Manual Antimicrobial Susceptibility Test Systems
LIE
Reagent/Device, Inoculum Calibration
LKA
Culture Media, Antimicrobial Susceptibility Test
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
LOP
Solution, Antimicrobial
LRG
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
LTT
Panels, Test, Susceptibility, Antimicrobial
LTW
Susceptibility Test Cards, Antimicrobial
LTX
Discs, Elution
MJA
Susceptibility Test Powders, Antimycobacterial
MJD
Culture Media, Antimycobacteria, Susceptibility Test
MJE
Culture Media, Antifungal, Susceptibility Test
MYI
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
NGZ
Susceptibility Test Plate, Antifungal
NIJ
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
PMY
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
POC
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
PRH
Positive Blood Culture Identification And Ast Kit
PTJ
Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
QIV
Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
QZX
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Serological Reagents
Subpart F—Immunological Test Systems
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
MI
/
subpart-b—diagnostic-devices
/
JTT
/
N50042
View Source
POTASSIUM PENICILLIN G DIAG SYS POWDER
Page Type
PMA Approval
Applicant
PFIZER, INC.
Trade Name
POTASSIUM PENICILLIN G DIAG SYS POWDER
Generic Name
Susceptibility test powders, antimicrobial
Decision Date
2/27/1970
Days to Decision
25624 days
Decision Code
APRL
FDA Decision
Reclassification after approval