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

Enzyme Linked Immunoabsorbent Assay, Rotavirus

21 CFR 866.3405 / Microbiology
FDA source (opens on fda.gov)

LIQ is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Rotavirus, a class I device type, regulated under 21 CFR 866.3405. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LIQ
Device name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Regulation
21 CFR 866.3405
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
33
Ingested recalls
2

Clearances, product code LIQ

By decision year
33 clearances under product code LIQ with a decision year between 1984 and 1999, 1985 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LIQ by decision year
YearClearances
19843
19855
19865
19874
19881
19893
19911
19922
19931
19942
19961
19974
19991

Applicants with the most clearances

Product code LIQ
Applicants holding the most 510(k) clearances under product code LIQ
ApplicantClearances
Meridian Diagnostics, Inc.3
Orion Diagnostica, Inc.3
Abbott Medical2
Biomerieux Vitek, Inc.2
Intl. Diagnostic Laboratories, Ltd.2
Kallestad Laboratories, Inc.2
Ortho Diagnostic Systems, Inc.2
Wellcome Diagnostics2
Armkel, LLC1
Bartels Immunodiagnostic Supplies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order