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510(k) K874429

HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 by Hf Scientific, Inc. — Product Code GIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1988
Date Received
October 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin S
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

Other clearances by Hf Scientific, Inc.

  • K882801 — RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. (August 29, 1988)
  • K880967 — MICRO CO2 APPARATUS (April 28, 1988)
  • K864313 — CO2 REAGENT SET (March 13, 1987)
  • K864862 — REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. (February 20, 1987)

Other clearances for product code GIQ

  • K955719 — SICKLE-2000 (August 14, 1996)
  • K942276 — QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (January 20, 1995)