AMERLITE CK-MB ASSAY— 510(k) K912766

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K912766 for AMERLITE CK-MB ASSAY, Substantially Equivalent on 1991-07-17. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1991-06-24
Decision date: 1991-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Amersham Corp.

K914135 — AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/20861992-02-18
K912733 — AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT1991-07-22
K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/20081990-11-02
K902760 — AMERSHAM TSH CONTROL SERA1990-07-27
K901832 — GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.104151990-07-09

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