CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.— 510(k) K873348

Name: FDA 510(k) clearance K873348
Creator: U.S. Food and Drug Administration
Published: 1987-09-09

Substantially Equivalent

Abbott Diagnostics

FDA 510(k) clearance K873348 for CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG., Substantially Equivalent on 1987-09-09. Applicant: Abbott Diagnostics. Device class: 1.

Clearance details

Applicant: Abbott Diagnostics
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1987-08-20
Decision date: 1987-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT1987-10-20
K863114 — PIASTRINIT1986-11-06
K863503 — HEMOLYSE1986-10-03

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