FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM— 510(k) K851450

Name: FDA 510(k) clearance K851450
Creator: U.S. Food and Drug Administration
Published: 1985-09-16

Substantially Equivalent

Flow Cytometry Standards Corp.

FDA 510(k) clearance K851450 for FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM, Substantially Equivalent on 1985-09-16. Applicant: Flow Cytometry Standards Corp.. Device class: 2.

Clearance details

Applicant: Flow Cytometry Standards Corp.
Product code: Code JIW
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1985-04-11
Decision date: 1985-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIW

view all

K973055 — WAKO CH50 LINEARITY SET1997-09-25
K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR1997-02-20
K910255 — FLOW CYTOMETRY FITC/PE COMPENSATION KIT1991-04-03
K902575 — SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)1990-10-04
K902294 — ACCUSCAN MICROBEAD STANDARDS1990-07-03

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