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

Platelet Factor 4 Radioimmunoassay

21 CFR 864.7695 / Hematology
FDA source (opens on fda.gov)

LCO is the FDA product code for Platelet Factor 4 Radioimmunoassay, a class II device type, regulated under 21 CFR 864.7695. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
LCO
Device name
Platelet Factor 4 Radioimmunoassay
Regulation
21 CFR 864.7695
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
13
Ingested recalls
11

Clearances, product code LCO

By decision year
13 clearances under product code LCO with a decision year between 1986 and 2025, 2007 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LCO by decision year
YearClearances
19861
19891
19991
20011
20041
20061
20072
20161
20171
20202
20251

Applicants with the most clearances

Product code LCO
Applicants holding the most 510(k) clearances under product code LCO
ApplicantClearances
Immucor GTI Diagnostics, Inc.5
Instrumentation Laboratory Co.2
Akers Laboratories, Inc.1
American Bioproducts Co.1
Behring Diagnostics, Inc.1
Diagnostica Stago, Inc.1
Hyphen Biomed Sasu1
Instrumentation Laboratory (IL) Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code