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

Lipoprotein X, Antigen, Antiserum, Control

21 CFR 866.5590 / Immunology
FDA source (opens on fda.gov)

DEL is the FDA product code for Lipoprotein X, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5590. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DEL
Device name
Lipoprotein X, Antigen, Antiserum, Control
Regulation
21 CFR 866.5590
Device class
Class I
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code DEL

By decision year
5 clearances under product code DEL with a decision year between 1989 and 2001, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DEL by decision year
YearClearances
19892
19902
20011

Applicants with the most clearances

Product code DEL
Applicants holding the most 510(k) clearances under product code DEL
ApplicantClearances
Sigma Chemical Co.2
Catachem, Inc.1
Medical Marketing Consultants, Inc.1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code