510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HJIClass I

Lens, Fundus, Hruby, Diagnostic

21 CFR 886.1395 / Ophthalmic
FDA source (opens on fda.gov)

HJI is the FDA product code for Lens, Fundus, Hruby, Diagnostic, a class I device type, regulated under 21 CFR 886.1395. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HJI
Device name
Lens, Fundus, Hruby, Diagnostic
Regulation
21 CFR 886.1395
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code HJI

By decision year
8 clearances under product code HJI with a decision year between 1976 and 1992, 1990 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HJI by decision year
YearClearances
19761
19812
19821
19903
19921

Applicants with the most clearances

Product code HJI
Applicants holding the most 510(k) clearances under product code HJI
ApplicantClearances
Cooper Medical Devices Corp.2
Academic Catalyst Corp.1
Canon Medical Components U.S.A., Inc.1
Innovision Medical, Inc.1
Ocular Instruments, Inc.1
Optical Micro Systems, Inc.1
Richard'S Medical Equip., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code