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

Flame Photometry, Potassium

21 CFR 862.1600 / Clinical Chemistry
FDA source (opens on fda.gov)

JGM is the FDA product code for Flame Photometry, Potassium, a class II device type, regulated under 21 CFR 862.1600. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JGM
Device name
Flame Photometry, Potassium
Regulation
21 CFR 862.1600
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
5
Ingested recalls
0

Clearances, product code JGM

By decision year
5 clearances under product code JGM with a decision year between 1977 and 1989, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JGM by decision year
YearClearances
19771
19811
19831
19861
19891

Applicants with the most clearances

Product code JGM
Applicants holding the most 510(k) clearances under product code JGM
ApplicantClearances
Amresco, Inc.1
Data Medical Associates, Inc.1
Environmental Chemical Specialties1
Mallinckrodt Critical Care1
Medical Specialties Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code JGM.