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

Haploscope

21 CFR 886.1340 / Ophthalmic
FDA source (opens on fda.gov)

HJT is the FDA product code for Haploscope, a class I device type, regulated under 21 CFR 886.1340. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HJT
Device name
Haploscope
Regulation
21 CFR 886.1340
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code HJT

By decision year
2 clearances under product code HJT with a decision year between 2001 and 2001, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HJT by decision year
YearClearances
20012

Applicants with the most clearances

Product code HJT
Applicants holding the most 510(k) clearances under product code HJT
ApplicantClearances
Neurovision, Inc.1
Optical Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code