Cleared Traditional

K854873 - INTRAOCULAR PRESSURE REDUCER
(FDA 510(k) Clearance)

K854873 · Mira, Inc. · Toxicology

Feb 1986

Decision

62d

Days

Class 2

Risk

K854873 is an FDA 510(k) clearance for the INTRAOCULAR PRESSURE REDUCER, a Fluorescent Immunoassay, Tobramycin (Class II — Special Controls, product code LCR), submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on February 4, 1986, 62 days after receiving the submission on December 4, 1985. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number	K854873 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 1985
Decision Date	February 04, 1986
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—