H292— 510(k) K942820

Substantially Equivalent

Bartels, Inc.

FDA 510(k) clearance K942820 for H292, Substantially Equivalent on 1995-05-05. Applicant: Bartels, Inc.. Device class: 1.

Clearance details

Applicant: Bartels, Inc.
Product code: Code KIR
Device class: Class 1
Regulation: 21 CFR 864.2280
Advisory panel: Hematology
Date received: 1994-06-15
Decision date: 1995-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issaquah, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIR

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K973212 — FRESH CELLS WI-381997-09-25
K973213 — FRESH CELLS LLC-MK21997-09-25

More clearances from Bartels, Inc.

K962499 — ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER1996-09-05

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