Atlas FDA

RIANEN 3H

FDA premarket approval P800061/S003 · decided 1982-12-22

Approval details

PMA number
P800061
Supplement
S003
Trade name
RIANEN 3H
Generic name
KIT, ASSAY, ESTROGEN RECEPTOR
Applicant
Dupont Legal
Date received
1982-10-18
Decision date
1982-12-22
Days to decision
65 days
Decision code
APPR
Product code
LPJ
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Wilmington, DE

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