SICKLE-CHEX SOLUBILITY KIT— 510(k) K023656

Name: FDA 510(k) clearance K023656
Creator: U.S. Food and Drug Administration
Published: 2002-12-30

Substantially Equivalent

Streck Laboratories, Inc.

FDA 510(k) clearance K023656 for SICKLE-CHEX SOLUBILITY KIT, Substantially Equivalent on 2002-12-30. 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: 2002-10-30
Decision date: 2002-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GHM

view all

K013316 — SICKLE-CHEX2001-11-06
K960947 — SAS SICKLE CELL TEST1996-07-01
K911981 — HEMOCARD HEMOGLOBIN S1991-10-09
K910430 — HEMOCARD-AS1991-04-15
K872217 — THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT1987-07-31

More clearances from Streck Laboratories, Inc.

view all

K042587 — RETIC-CHEX FOR CELL-DYN2004-10-19
K040107 — CYTO-CHEX BCT2004-07-27
K040025 — A1C-CELLULAR2004-03-02
K021922 — MODIFICATION TO PARA 5X2002-06-25
K020469 — CAL-CHEX CD PLUS2002-04-04

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