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

Colorimetric Method, Lecithin/Sphingomyelin Ratio

21 CFR 862.1455 / Clinical Chemistry
FDA source (opens on fda.gov)

JHF is the FDA product code for Colorimetric Method, Lecithin/Sphingomyelin Ratio, a class II device type, regulated under 21 CFR 862.1455. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JHF
Device name
Colorimetric Method, Lecithin/Sphingomyelin Ratio
Regulation
21 CFR 862.1455
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
2
Ingested recalls
0

Clearances, product code JHF

By decision year
2 clearances under product code JHF with a decision year between 1989 and 1995, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JHF by decision year
YearClearances
19891
19951

Applicants with the most clearances

Product code JHF
Applicants holding the most 510(k) clearances under product code JHF
ApplicantClearances
Abbott Medical1
Isolab, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code JHF.