AMERLEX DIGOXIN RIA KIT— 510(k) K801413

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K801413 for AMERLEX DIGOXIN RIA KIT, Substantially Equivalent on 1980-07-08. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code LCS
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1980-06-16
Decision date: 1980-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K874748 — IMMPULSE DIGOXIN ASSAY REAGENTS1988-02-19

More clearances from Amersham Corp.

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.