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

Solution, Isotonic

21 CFR 864.4010 / Pathology
FDA source (opens on fda.gov)

JCE is the FDA product code for Solution, Isotonic, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JCE
Device name
Solution, Isotonic
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code JCE

By decision year
7 clearances under product code JCE with a decision year between 1977 and 1984, 1977 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JCE by decision year
YearClearances
19773
19791
19801
19831
19841

Applicants with the most clearances

Product code JCE
Applicants holding the most 510(k) clearances under product code JCE
ApplicantClearances
Bio/Data Corp.2
Central Labs. Assoc. MD Pathologists1
Coulter Electronics, Inc.1
E K Ind., Inc.1
EMD Millipore Corporation1
Nobel Scientific Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order