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

Osmometer For Clinical Use

21 CFR 862.2730 / Clinical Chemistry
FDA source (opens on fda.gov)

JJM is the FDA product code for Osmometer For Clinical Use, a class I device type, regulated under 21 CFR 862.2730. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
JJM
Device name
Osmometer For Clinical Use
Regulation
21 CFR 862.2730
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
12
Ingested recalls
3

Clearances, product code JJM

By decision year
12 clearances under product code JJM with a decision year between 1979 and 1997, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JJM by decision year
YearClearances
19791
19811
19831
19844
19871
19911
19931
19961
19971

Applicants with the most clearances

Product code JJM
Applicants holding the most 510(k) clearances under product code JJM
ApplicantClearances
Advanced Instruments, LLC7
ELITechGroup Inc2
Fiske Med Science1
Kyoto Diagnostics, Inc.1
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code