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

Olive Oil Emulsion (Turbidimetric), Lipase

21 CFR 862.1465 / Clinical Chemistry
FDA source (opens on fda.gov)

CET is the FDA product code for Olive Oil Emulsion (Turbidimetric), Lipase, a class I device type, regulated under 21 CFR 862.1465. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CET
Device name
Olive Oil Emulsion (Turbidimetric), Lipase
Regulation
21 CFR 862.1465
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
0

Clearances, product code CET

By decision year
15 clearances under product code CET with a decision year between 1977 and 1997, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CET by decision year
YearClearances
19771
19793
19811
19831
19851
19861
19871
19892
19901
19921
19941
19971

Applicants with the most clearances

Product code CET
Applicants holding the most 510(k) clearances under product code CET
ApplicantClearances
E.I. Dupont de Nemours & Co., Inc.2
Alta Diagnostics, Inc.1
American Dade1
Beckman Instruments, Inc.1
Behring Diagnostics, Inc.1
Dade, Baxter Travenol Diagnostics, Inc.1
Electro-Nucleonics, Inc.1
Mallinckrodt Critical Care1
Medical Analysis Systems, Inc.1
Medical Diagnostic Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code