ACTIN FSL ACTIVATED PTT REAGENT— 510(k) K863594

Substantially Equivalent

American Dade

FDA 510(k) clearance K863594 for ACTIN FSL ACTIVATED PTT REAGENT, Substantially Equivalent on 1986-10-17. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1986-09-15
Decision date: 1986-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Dade

K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

Recalls naming K863594

K-number listed on FDA's recall record

Z-1073-2013 — Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20130311

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K863594.

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