HEMAPROMPT GASTRIC— 510(k) K031356

Substantially Equivalent

Aerscher Diagnostics

FDA 510(k) clearance K031356 for HEMAPROMPT GASTRIC, Substantially Equivalent on 2003-09-24. Applicant: Aerscher Diagnostics. Device class: 2.

Clearance details

Applicant: Aerscher Diagnostics
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2003-04-11
Decision date: 2003-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chestertown, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Aerscher Diagnostics

K981661 — HEMAPROMPT1998-09-15
K972763 — HEMAPROMPT1997-10-20

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