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

Automated Radioimmunoassay Systems, For Clinical Use

21 CFR 862.2050 / Clinical Chemistry
FDA source (opens on fda.gov)

LCI is the FDA product code for Automated Radioimmunoassay Systems, For Clinical Use, a class I device type, regulated under 21 CFR 862.2050. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LCI
Device name
Automated Radioimmunoassay Systems, For Clinical Use
Regulation
21 CFR 862.2050
Device class
Class I
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
3
Ingested recalls
1

Clearances, product code LCI

By decision year
3 clearances under product code LCI with a decision year between 1978 and 1998, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LCI by decision year
YearClearances
19781
19801
19981

Applicants with the most clearances

Product code LCI
Applicants holding the most 510(k) clearances under product code LCI
ApplicantClearances
Beckman Instruments, Inc.1
Diasorin Inc.1
Union Carbide Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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