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
LCWClass II

Radioimmunoassay, Digitoxin (125-I)

21 CFR 862.3300 / Clinical Toxicology
FDA source (opens on fda.gov)

LCW is the FDA product code for Radioimmunoassay, Digitoxin (125-I), a class II device type, regulated under 21 CFR 862.3300. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LCW
Device name
Radioimmunoassay, Digitoxin (125-I)
Regulation
21 CFR 862.3300
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code LCW

By decision year
3 clearances under product code LCW with a decision year between 1978 and 1984, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LCW by decision year
YearClearances
19781
19801
19841

Applicants with the most clearances

Product code LCW
Applicants holding the most 510(k) clearances under product code LCW
ApplicantClearances
Cambridge Medical Technology1
Siemens Healthcare Diagnostics Inc.1
IMMUNOTECH s.r.o.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LCW.