TOTAL ESTRIOL RIA KIT— 510(k) K800036

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K800036 for TOTAL ESTRIOL RIA KIT, Substantially Equivalent on 1980-01-21. Applicant: Amersham Corp.. Device class: 1.

Clearance details

Applicant: Amersham Corp.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1980-01-07
Decision date: 1980-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.