IDL-LYSING REAGENT— 510(k) K842069

Name: FDA 510(k) clearance K842069
Creator: U.S. Food and Drug Administration
Published: 1984-07-02

Substantially Equivalent

Interscience Diagnostics, Inc.

FDA 510(k) clearance K842069 for IDL-LYSING REAGENT, Substantially Equivalent on 1984-07-02. Applicant: Interscience Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Interscience Diagnostics, Inc.
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1984-05-23
Decision date: 1984-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.1987-09-09
K863114 — PIASTRINIT1986-11-06

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K854166 — HEMATOLOGY CALIBRATOR CONTROL1986-03-12
K842068 — IDI ISOTONIC DILUENT1984-07-02
K842070 — IDD DETERGENT1984-07-02

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