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

Clinical Sample Concentrator

21 CFR 862.2310 / Clinical Chemistry
FDA source (opens on fda.gov)

JJH is the FDA product code for Clinical Sample Concentrator, a class I device type, regulated under 21 CFR 862.2310. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 31 recalls.

Classification record

Product code
JJH
Device name
Clinical Sample Concentrator
Regulation
21 CFR 862.2310
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
15
Ingested recalls
31

Clearances, product code JJH

By decision year
15 clearances under product code JJH with a decision year between 1976 and 2012, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JJH by decision year
YearClearances
19761
19771
19801
19841
19851
19872
19891
19931
19942
19952
19961
20121

Applicants with the most clearances

Product code JJH
Applicants holding the most 510(k) clearances under product code JJH
ApplicantClearances
Amicon, Inc.6
Vivascience, Inc.3
Clinical Micro Sensors, Inc.1
E.I. Dupont de Nemours & Co., Inc.1
Intersep, Ltd.1
EMD Millipore Corporation1
Polysciences, Inc.1
Radiation Technology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 94 companies shown, in name order