CAL-CHEX, A HEMATOLOGY CALIBRATOR— 510(k) K840261

Name: FDA 510(k) clearance K840261
Creator: U.S. Food and Drug Administration
Published: 1984-02-21

Substantially Equivalent

Streck Laboratories, Inc.

FDA 510(k) clearance K840261 for CAL-CHEX, A HEMATOLOGY CALIBRATOR, Substantially Equivalent on 1984-02-21. Applicant: Streck Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Streck Laboratories, Inc.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1984-01-05
Decision date: 1984-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRZ

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K052101 — C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C2005-08-26
K041130 — CDS HEMATOLOGY CALIBRATOR (CDS CAL)2004-06-10
K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS1996-12-18
K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS1995-07-24
K902892 — CELL-DYN CALIBRATOR1990-09-10

More clearances from Streck Laboratories, Inc.

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K042587 — RETIC-CHEX FOR CELL-DYN2004-10-19
K040107 — CYTO-CHEX BCT2004-07-27
K040025 — A1C-CELLULAR2004-03-02
K023656 — SICKLE-CHEX SOLUBILITY KIT2002-12-30
K021922 — MODIFICATION TO PARA 5X2002-06-25

Recalls naming K840261

K-number listed on FDA's recall record

Z-2086-2025 — ADVIA¿ 120/2120/2120i SETpoint CalibratorClass II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20250604

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K840261.

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