RADIOMHTER OSM-2 HEMOXIMETER— 510(k) K771263

Substantially Equivalent

The London Co.

FDA 510(k) clearance K771263 for RADIOMHTER OSM-2 HEMOXIMETER, Substantially Equivalent on 1977-08-03. Applicant: The London Co.. Device class: 2.

Clearance details

Applicant: The London Co.
Product code: Code GHS
Device class: Class 2
Regulation: 21 CFR 864.7425
Advisory panel: Hematology
Date received: 1977-07-11
Decision date: 1977-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from The London Co.

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K780652 — HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-21978-07-27
K771444 — QUALICHECK TM1977-08-16

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