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

5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

21 CFR 862.1520 / Clinical Chemistry
FDA source (opens on fda.gov)

CED is the FDA product code for 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase, a class I device type, regulated under 21 CFR 862.1520. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CED
Device name
5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
Regulation
21 CFR 862.1520
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
9
Ingested recalls
0

Clearances, product code CED

By decision year
9 clearances under product code CED with a decision year between 1979 and 1989, 1981 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CED by decision year
YearClearances
19791
19801
19813
19821
19842
19891

Applicants with the most clearances

Product code CED
Applicants holding the most 510(k) clearances under product code CED
ApplicantClearances
Union Carbide Corp.2
American Monitor Corp.1
Btc Diagnostics, Inc.1
Connecticut Diagnostics, Ltd.1
Eastman Kodak Company1
Em Diagnostic Systems, Inc.1
Sandare Chemical Co., Inc.1
Sigma Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code