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

Radioassay, Intrinsic Factor Blocking Antibody

21 CFR 862.1810 / Clinical Chemistry
FDA source (opens on fda.gov)

LIG is the FDA product code for Radioassay, Intrinsic Factor Blocking Antibody, a class II device type, regulated under 21 CFR 862.1810. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
LIG
Device name
Radioassay, Intrinsic Factor Blocking Antibody
Regulation
21 CFR 862.1810
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
3

Clearances, product code LIG

By decision year
8 clearances under product code LIG with a decision year between 1982 and 2024, 1999 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LIG by decision year
YearClearances
19821
19901
19992
20031
20061
20071
20241

Applicants with the most clearances

Product code LIG
Applicants holding the most 510(k) clearances under product code LIG
ApplicantClearances
Siemens Healthcare Diagnostics Inc.3
Abbott Medical2
Corning Medical & Scientific1
Immco Diagnostics, Inc.1
Inova Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code