CELL-CHEX— 510(k) K000076

Substantially Equivalent

Streck Laboratories, Inc.

FDA 510(k) clearance K000076 for CELL-CHEX, Substantially Equivalent on 2000-03-03. Applicant: Streck Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Streck Laboratories, Inc.
Product code: Code GJR
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2000-01-10
Decision date: 2000-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Omaha, NE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GJR

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K021922 — MODIFICATION TO PARA 5X2002-06-25

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