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

Fluorometric, Calcium

21 CFR 862.1145 / Clinical Chemistry
FDA source (opens on fda.gov)

JFO is the FDA product code for Fluorometric, Calcium, a class II device type, regulated under 21 CFR 862.1145. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
JFO
Device name
Fluorometric, Calcium
Regulation
21 CFR 862.1145
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
1
Ingested recalls
1

Clearances, product code JFO

By decision year
1 clearance under product code JFO with a decision year between 1992 and 1992, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JFO by decision year
YearClearances
19921

Applicants with the most clearances

Product code JFO
Applicants holding the most 510(k) clearances under product code JFO
ApplicantClearances
Remel Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code