Atlas FDA

MURINER LUBRICATING & REWETTING DROPS

FDA premarket approval P880056/S001 · decided 1989-10-13

Approval details

PMA number
P880056
Supplement
S001
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
MURINER LUBRICATING & REWETTING DROPS
Generic name
Accessories, soft lens products
Applicant
Abbott Laboratories
Date received
1989-04-21
Decision date
1989-10-13
Days to decision
175 days
Decision code
APPR
Product code
LPN
Advisory committee
Ophthalmic
Expedited review
No
Location
Columbus, OH

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

510(k) clearances by this applicant

RecordFirmDate
Anti-HCV Next (K252424)Abbott Laboratories2026-04-28
ARCHITECT iGentamicin (K243500)Abbott Laboratories2025-07-09
Alinity i Rubella IgG (K243168)Abbott Laboratories2025-06-20
Alinity h-series System (K243283)Abbott Laboratories2025-02-20
Alinity i Toxo IgM (K233932)Abbott Laboratories2024-08-30
TBI (K232669)Abbott Laboratories2023-09-29
HAVAb IgG II (K222850)Abbott Laboratories2023-08-10
Alinity h-series System (K220031)Abbott Laboratories2023-08-04