ABBOTT RSV EIA— 510(k) K852472

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K852472 for ABBOTT RSV EIA, Substantially Equivalent on 1985-09-17. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LKT
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1985-06-11
Decision date: 1985-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKT

K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT2008-12-23
K983336 — PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP11999-03-18
K943317 — PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)1994-12-19
K942173 — RSV ANTIGEN TEST1994-06-30
K912842 — RSV-MAB TEST1991-12-09

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Data sourced from openFDA. This site is unofficial and independent of the FDA.