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

Visual, Pregnancy Hcg, Prescription Use

21 CFR 862.1155 / Clinical Chemistry
FDA source (opens on fda.gov)

JHI is the FDA product code for Visual, Pregnancy Hcg, Prescription Use, a class II device type, regulated under 21 CFR 862.1155. As of , FDA records hold 375 510(k) clearances under this code, the most recent dated , and 43 recalls.

Classification record

Product code
JHI
Device name
Visual, Pregnancy Hcg, Prescription Use
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
376
Ingested recalls
47

Clearances, product code JHI

By decision year
376 clearances under product code JHI with a decision year between 1976 and 2026, 1985 the highest year at 25.
Show the numbers
510(k) clearances under FDA product code JHI by decision year
YearClearances
19761
19772
19786
19798
19804
19818
198217
198315
198420
198525
198613
198722
198817
198918
199014
199114
199215
199315
19948
199513
199613
199722
199815
199917
20002
20018
200210
20038
20043
20054
20062
20074
20101
20122
20132
20142
20161
20171
20181
20221
20241
20261

Applicants with the most clearances

Product code JHI
Applicants holding the most 510(k) clearances under product code JHI
ApplicantClearances
Ortho-Clinical Diagnostics, Inc.20
Abbott Medical15
Hybritech, Inc.14
Pacific Biotech, Inc.13
Leeco Diagnostics, Inc.10
BD Becton Dickinson Vacutainer Systems Preanalytic9
Medix Biotech, Inc.9
SA Scientific, Ltd9
Siemens Healthcare Diagnostics Inc.7
Hoffmann-La Roche, Inc.7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 95 companies shown, in name order