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

Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen

21 CFR 862.1590 / Clinical Chemistry
FDA source (opens on fda.gov)

JNF is the FDA product code for Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen, a class I device type, regulated under 21 CFR 862.1590. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
JNF
Device name
Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
Regulation
21 CFR 862.1590
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
1
Ingested recalls
0

Clearances, product code JNF

By decision year
1 clearance under product code JNF with a decision year between 1996 and 1996, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JNF by decision year
YearClearances
19961

Applicants with the most clearances

Product code JNF
Applicants holding the most 510(k) clearances under product code JNF
ApplicantClearances
Trace America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code