HBM HEMOGLOBINOMETER— 510(k) K933836

Substantially Equivalent

Artel, Inc.

FDA 510(k) clearance K933836 for HBM HEMOGLOBINOMETER, Substantially Equivalent on 1994-03-31. Applicant: Artel, Inc.. Device class: 2.

Clearance details

Applicant: Artel, Inc.
Product code: Code GIG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1993-08-05
Decision date: 1994-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, ME, US

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Recent devices under product code GIG

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K771101 — HEMOGLOBIN ANALYZER & PERFORM. CHECK SET1977-07-21

More clearances from Artel, Inc.

K920914 — MP/S SINGLE WAVELENGTH MINI PHOTOMETER1992-03-23
K914809 — MP MINI PHOTOMETER1992-01-27
K864542 — ARTEL DIFFERENTIAL PHOTOMETER1987-02-06

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