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

Antisera, Conjugated Fluorescent, Cytomegalovirus

21 CFR 866.3175 / Microbiology
FDA source (opens on fda.gov)

LIN is the FDA product code for Antisera, Conjugated Fluorescent, Cytomegalovirus, a class II device type, regulated under 21 CFR 866.3175. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LIN
Device name
Antisera, Conjugated Fluorescent, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
17
Ingested recalls
0

Clearances, product code LIN

By decision year
17 clearances under product code LIN with a decision year between 1982 and 2008, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LIN by decision year
YearClearances
19822
19851
19861
19893
19901
19912
19921
19941
19962
19992
20081

Applicants with the most clearances

Product code LIN
Applicants holding the most 510(k) clearances under product code LIN
ApplicantClearances
Bartels Immunodiagnostic Supplies, Inc.2
Baxter Healthcare Corporation2
Biotest Diagnostics Corp.2
IMMUNO CONCEPTS, NA, Ltd.2
Ortho-Clinical Diagnostics, Inc.1
Siemens Healthcare Diagnostics Inc.1
Gull Laboratories, Inc.1
Immulok, Inc.1
Incstar Corp.1
Light Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code