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Innolitics
Anesthesiology
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Subpart B—Biological Stains
CFR Sub-Part
LPI
Kit, Assay, Progesterone Receptor
3
Product Code
LPJ
Kit, Assay, Estrogen Receptor
3
Product Code
P
85
0029
ABBOTT ER-EIA MONOCLONAL DIAG. KIT
APWD
PMA Approval
P
88
0026
ABBOTT ER-ICA MONOCLONAL
APWD
PMA Approval
P
86
0015
FLUORO-CEP{R} ESTROGEN ASSAY REAGENT
APWD
PMA Approval
P
80
0061
RIANEN 3H
APWD
PMA Approval
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
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Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Clinical Toxicology Test Systems
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
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Subpart D—Serological Reagents
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Subpart F—General Hospital and Personal Use Therapeutic Devices
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Subpart F—Immunological Test Systems
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Dental
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Last synced on 13 June 2025 at 11:06 pm
CH
/
subpart-b—biological-stains
/
LPJ
/
P800061
View Source
RIANEN 3H
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
DUPONT LEGAL
Trade Name
RIANEN 3H
Generic Name
KIT, ASSAY, ESTROGEN RECEPTOR
Decision Date
6/1/1981
Days to Decision
222 days
Decision Code
APWD
FDA Decision
Withdrawal after approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Miscellaneous
Subpart B—Biological Stains
LPI
Kit, Assay, Progesterone Receptor
LPJ
Kit, Assay, Estrogen Receptor
P
85
0029
ABBOTT ER-EIA MONOCLONAL DIAG. KIT
P
88
0026
ABBOTT ER-ICA MONOCLONAL
P
86
0015
FLUORO-CEP{R} ESTROGEN ASSAY REAGENT
P
80
0061
RIANEN 3H
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Clinical Toxicology Test Systems
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Serological Reagents
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Immunological Test Systems
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CH
/
subpart-b—biological-stains
/
LPJ
/
P800061
View Source
RIANEN 3H
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
DUPONT LEGAL
Trade Name
RIANEN 3H
Generic Name
KIT, ASSAY, ESTROGEN RECEPTOR
Decision Date
6/1/1981
Days to Decision
222 days
Decision Code
APWD
FDA Decision
Withdrawal after approval