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

Turbidimetric Method, Lipoproteins

21 CFR 862.1475 / Clinical Chemistry
FDA source (opens on fda.gov)

JHN is the FDA product code for Turbidimetric Method, Lipoproteins, a class I device type, regulated under 21 CFR 862.1475. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JHN
Device name
Turbidimetric Method, Lipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
1

Clearances, product code JHN

By decision year
7 clearances under product code JHN with a decision year between 1994 and 1995, 1995 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JHN by decision year
YearClearances
19942
19955

Applicants with the most clearances

Product code JHN
Applicants holding the most 510(k) clearances under product code JHN
ApplicantClearances
OLYMPUS Corporation of the Americas2
Randox Laboratories, Limited2
Sigma Diagnostics, Inc.2
FUJIFILM Healthcare Americas Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code