NEOPLASTINE CI PLUS— 510(k) K922040

Name: FDA 510(k) clearance K922040
Creator: U.S. Food and Drug Administration
Published: 1992-06-23

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K922040 for NEOPLASTINE CI PLUS, Substantially Equivalent on 1992-06-23. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 1992-05-01
Decision date: 1992-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K922040

K-number listed on FDA's recall record

Z-2993-2018 — Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).Class II·Terminated·Diagnostica Stago, Inc.·20180724
Z-1066-2018 — Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).Class II·Terminated·Diagnostica Stago, Inc.·20171025
Z-1067-2018 — Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).Class II·Terminated·Diagnostica Stago, Inc.·20171025
Z-1069-2018 — STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).Class II·Terminated·Diagnostica Stago, Inc.·20171025

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K922040.

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