ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT— 510(k) K760318

Name: FDA 510(k) clearance K760318
Creator: U.S. Food and Drug Administration
Published: 1976-08-03

Substantially Equivalent

Dade, Baxter Travenol Diagnostics, Inc.

FDA 510(k) clearance K760318 for ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT, Substantially Equivalent on 1976-08-03. Applicant: Dade, Baxter Travenol Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Dade, Baxter Travenol Diagnostics, Inc.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1976-07-26
Decision date: 1976-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K760318

K-number listed on FDA's recall record

Z-1703-2015 — Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20150325

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K760318.

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