PARA TECH PLUS RETICS— 510(k) K993825

Name: FDA 510(k) clearance K993825
Creator: U.S. Food and Drug Administration
Published: 1999-11-30

Substantially Equivalent

Streck Laboratories, Inc.

FDA 510(k) clearance K993825 for PARA TECH PLUS RETICS, Substantially Equivalent on 1999-11-30. Applicant: Streck Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Streck Laboratories, Inc.
Product code: Code JCN
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1999-11-12
Decision date: 1999-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Omaha, NE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCN

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K942209 — LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH1994-06-16
K934497 — CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE1993-12-06
K911582 — STAK-CHEX1991-05-28
K902389 — TRI-COUNT 161990-08-22
K902391 — CELL-DYN 3000 CONTROL1990-08-22

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 K993825

K-number listed on FDA's recall record

Z-2087-2025 — ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20250604
Z-2088-2025 — ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20250604
Z-2089-2025 — ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)Class 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 K993825.

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