510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DESClass II

Lambda, Fitc, Antigen, Antiserum, Control

21 CFR 866.5550 / Immunology
FDA source (opens on fda.gov)

DES is the FDA product code for Lambda, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5550. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DES
Device name
Lambda, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code DES

By decision year
2 clearances under product code DES with a decision year between 1983 and 1983, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DES by decision year
YearClearances
19832

Applicants with the most clearances

Product code DES
Applicants holding the most 510(k) clearances under product code DES
ApplicantClearances
Dako Corp.1
Gelco Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code