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

Apparatus, Electrophoresis, For Clinical Use

21 CFR 862.2485 / Clinical Chemistry
FDA source (opens on fda.gov)

JJN is the FDA product code for Apparatus, Electrophoresis, For Clinical Use, a class I device type, regulated under 21 CFR 862.2485. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JJN
Device name
Apparatus, Electrophoresis, For Clinical Use
Regulation
21 CFR 862.2485
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
34
Ingested recalls
1

Clearances, product code JJN

By decision year
34 clearances under product code JJN with a decision year between 1976 and 1993, 1980 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code JJN by decision year
YearClearances
19762
19773
19792
19806
19811
19825
19831
19844
19852
19861
19872
19882
19891
19921
19931

Applicants with the most clearances

Product code JJN
Applicants holding the most 510(k) clearances under product code JJN
ApplicantClearances
Helena Laboratories, Corp.8
Gelman Sciences, Inc.5
Corning Medical & Scientific3
Electrophoresis Corp. of America3
Logos Scientific, Inc.3
Sartorius Filters, Inc.2
The Binding Site2
Electrophoresis Corp.1
Fmc Corp.1
Gilford Instrument Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order