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

Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

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

PYP is the FDA product code for Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test, a class I device type, regulated under 21 CFR 862.1475. FDA's definition for this code reads: "For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PYP
Device name
Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
FDA definition
For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
Regulation
21 CFR 862.1475
Device class
Class I
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
1
Ingested recalls
0

Clearances, product code PYP

By decision year
1 clearance under product code PYP with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PYP by decision year
YearClearances
20171

Applicants with the most clearances

Product code PYP
Applicants holding the most 510(k) clearances under product code PYP
ApplicantClearances
Denka Seiken Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code