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510(k) K933836

HBM HEMOGLOBINOMETER by Artel, Inc. — Product Code GIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1994
Date Received
August 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobinometer
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

Other clearances by Artel, Inc.

  • K920914 — MP/S SINGLE WAVELENGTH MINI PHOTOMETER (March 23, 1992)
  • K914809 — MP MINI PHOTOMETER (January 27, 1992)
  • K864542 — ARTEL DIFFERENTIAL PHOTOMETER (February 6, 1987)

Other clearances for product code GIG

  • K973995 — RANDOX BILIRUBIN (December 8, 1997)
  • K771101 — HEMOGLOBIN ANALYZER & PERFORM. CHECK SET (July 21, 1977)