ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS— 510(k) K871230

Name: FDA 510(k) clearance K871230
Creator: U.S. Food and Drug Administration
Published: 1987-06-26

Substantially Equivalent

Microscan Div. Baxter Healthcare Corp.

FDA 510(k) clearance K871230 for ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS, Substantially Equivalent on 1987-06-26. Applicant: Microscan Div. Baxter Healthcare Corp.. Device class: 1.

Clearance details

Applicant: Microscan Div. Baxter Healthcare Corp.
Product code: Code LKT
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1987-03-27
Decision date: 1987-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKT

view all

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

More clearances from Microscan Div. Baxter Healthcare Corp.

view all

K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 21987-06-26
K871229 — ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL1987-06-26
K871231 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B1987-06-26
K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 31987-06-26
K871233 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A1987-06-26

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