SICKLE-CHEX— 510(k) K013316

Substantially Equivalent

Streck Laboratories, Inc.

FDA 510(k) clearance K013316 for SICKLE-CHEX, Substantially Equivalent on 2001-11-06. Applicant: Streck Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Streck Laboratories, Inc.
Product code: Code GHM
Device class: Class 2
Regulation: 21 CFR 864.7825
Advisory panel: Hematology
Date received: 2001-10-04
Decision date: 2001-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

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K872217 — THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT1987-07-31

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K020469 — CAL-CHEX CD PLUS2002-04-04

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