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

Radioimmunoassay, Digoxin (125-I)

21 CFR 862.3320 / Clinical Toxicology
FDA source (opens on fda.gov)

LCS is the FDA product code for Radioimmunoassay, Digoxin (125-I), a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LCS
Device name
Radioimmunoassay, Digoxin (125-I)
Regulation
21 CFR 862.3320
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
15
Ingested recalls
0

Clearances, product code LCS

By decision year
15 clearances under product code LCS with a decision year between 1977 and 1992, 1980 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code LCS by decision year
YearClearances
19771
19806
19811
19821
19871
19881
19892
19911
19921

Applicants with the most clearances

Product code LCS
Applicants holding the most 510(k) clearances under product code LCS
ApplicantClearances
Abbott Medical1
Amersham Corp.1
Antibodies, Inc.1
Coulter Electronics, Inc.1
Cyberfluor, Inc.1
E. R. Squibb & Sons, Inc.1
Innotron of Oregon, Inc.1
M.A. Bioproducts1
Monobind, Inc.1
Pcl-Ria, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code