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

Oncometer, Plasma, For Clinical Use

21 CFR 862.2720 / Clinical Chemistry
FDA source (opens on fda.gov)

JJK is the FDA product code for Oncometer, Plasma, For Clinical Use, a class I device type, regulated under 21 CFR 862.2720. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JJK
Device name
Oncometer, Plasma, For Clinical Use
Regulation
21 CFR 862.2720
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
4
Ingested recalls
0

Clearances, product code JJK

By decision year
4 clearances under product code JJK with a decision year between 1977 and 1986, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JJK by decision year
YearClearances
19771
19801
19821
19861

Applicants with the most clearances

Product code JJK
Applicants holding the most 510(k) clearances under product code JJK
ApplicantClearances
Abbott Medical1
Boehringer Mannheim Corp.1
Instrumentation Laboratory Co.1
Nuclear Medical Laboratories, 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 JJK.