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

Fluorometric, Cortisol

21 CFR 862.1205 / Clinical Chemistry
FDA source (opens on fda.gov)

JFT is the FDA product code for Fluorometric, Cortisol, a class II device type, regulated under 21 CFR 862.1205. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
JFT
Device name
Fluorometric, Cortisol
Regulation
21 CFR 862.1205
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
20
Ingested recalls
5

Clearances, product code JFT

By decision year
20 clearances under product code JFT with a decision year between 1983 and 2025, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JFT by decision year
YearClearances
19831
19852
19861
19892
19901
19933
19941
19951
19961
20021
20041
20061
20151
20161
20191
20251

Applicants with the most clearances

Product code JFT
Applicants holding the most 510(k) clearances under product code JFT
ApplicantClearances
Roche Diagnostics GmbH3
Abbott Medical2
Ciba Corning Diagnostics Corp.2
Siemens Healthcare Diagnostics Inc.2
Baxter Healthcare Corporation1
Bio-Rad Laboratories Inc.1
Biomerieux Vitek, Inc.1
Fujirebio Diagnostics, Inc.1
Kallestad Diag, A Div. of Erbamont, Inc.1
Lkb Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code