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

Enzymatic Method, Bilirubin

21 CFR 862.1110 / Clinical Chemistry
FDA source (opens on fda.gov)

JFM is the FDA product code for Enzymatic Method, Bilirubin, a class II device type, regulated under 21 CFR 862.1110. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
JFM
Device name
Enzymatic Method, Bilirubin
Regulation
21 CFR 862.1110
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
11
Ingested recalls
9

Clearances, product code JFM

By decision year
11 clearances under product code JFM with a decision year between 1984 and 2017, 2005 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JFM by decision year
YearClearances
19841
19901
19971
20054
20071
20162
20171

Applicants with the most clearances

Product code JFM
Applicants holding the most 510(k) clearances under product code JFM
ApplicantClearances
FUJIFILM Healthcare Americas Corporation3
Siemens Healthcare Diagnostics Inc.2
Randox Laboratories, Limited2
Medrad, Inc.1
Beckman Instruments, Inc.1
Diagnostic Chemicals, Ltd. (USA)1
Stanbio Laboratory1

Companies listing this code with FDA

Companies whose registered establishments list this code