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

Enzymatic Methods, Galactose

21 CFR 862.1310 / Clinical Chemistry
FDA source (opens on fda.gov)

JIA is the FDA product code for Enzymatic Methods, Galactose, a class I device type, regulated under 21 CFR 862.1310. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
JIA
Device name
Enzymatic Methods, Galactose
Regulation
21 CFR 862.1310
Device class
Class I
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
9
Ingested recalls
6

Clearances, product code JIA

By decision year
9 clearances under product code JIA with a decision year between 1995 and 2019, 1999 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JIA by decision year
YearClearances
19951
19961
19993
20081
20131
20141
20191

Applicants with the most clearances

Product code JIA
Applicants holding the most 510(k) clearances under product code JIA
ApplicantClearances
Quantase, Ltd.2
Astoria-Pacific, Inc.1
Icn Pharmaceuticals, Inc.1
Isolab, Inc.1
Neometrics, Inc.1
Revvity Health Sciences, Inc.1
Wallac Oy1
Wallac Oy, A Subsidiary of Perkinelmer, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code