AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144— 510(k) K874362

Name: FDA 510(k) clearance K874362
Creator: U.S. Food and Drug Administration
Published: 1988-02-18

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K874362 for AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144, Substantially Equivalent on 1988-02-18. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1987-10-23
Decision date: 1988-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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K914135 — AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/20861992-02-18
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K912766 — AMERLITE CK-MB ASSAY1991-07-17
K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/20081990-11-02
K902760 — AMERSHAM TSH CONTROL SERA1990-07-27

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