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
MCEClass I

Respiratory Syncytial Virus - Elisa

21 CFR 866.3480 / Microbiology
FDA source (opens on fda.gov)

MCE is the FDA product code for Respiratory Syncytial Virus - Elisa, a class I device type, regulated under 21 CFR 866.3480. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MCE
Device name
Respiratory Syncytial Virus - Elisa
Regulation
21 CFR 866.3480
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code MCE

By decision year
2 clearances under product code MCE with a decision year between 1993 and 2006, 1993 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MCE by decision year
YearClearances
19931
20061

Applicants with the most clearances

Product code MCE
Applicants holding the most 510(k) clearances under product code MCE
ApplicantClearances
Bio-Rad Laboratories Inc.1
Ortho-Clinical Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code