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

Uranyl Acetate/Zinc Acetate, Sodium

21 CFR 862.1665 / Clinical Chemistry
FDA source (opens on fda.gov)

CEI is the FDA product code for Uranyl Acetate/Zinc Acetate, Sodium, a class II device type, regulated under 21 CFR 862.1665. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CEI
Device name
Uranyl Acetate/Zinc Acetate, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
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
4
Ingested recalls
0

Clearances, product code CEI

By decision year
4 clearances under product code CEI with a decision year between 1983 and 2005, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CEI by decision year
YearClearances
19831
19901
19911
20051

Applicants with the most clearances

Product code CEI
Applicants holding the most 510(k) clearances under product code CEI
ApplicantClearances
Mallinckrodt Critical Care1
Randox Laboratories, Limited1
Sterling Diagnostics, Inc.1
Tech Intl. Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code