AIA-PACK CORT ASSAY— 510(k) K954591

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K954591 for AIA-PACK CORT ASSAY, Substantially Equivalent on 1995-12-15. Applicant: Tosoh Medics, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code JFT
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1995-10-02
Decision date: 1995-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K954591

K-number listed on FDA's recall record

Z-2094-2018 — ST-AIA PACK Cort; Part Number: 025287 Assay, MetabolicClass II·Terminated·Tosoh Bioscience Inc·20180305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954591.

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