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510(k) K973649

HEMOSITE TEST SYSTEM by Gds Technology, LLC — Product Code KHG

K973649 is an FDA 510(k) premarket notification submitted by Gds Technology, LLC for the device "HEMOSITE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 31, 1998. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Gds Technology, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1998
Date Received
September 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Whole Blood Hemoglobin Determination
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

Other clearances by Gds Technology, LLC

  • K020138 — STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARD (February 11, 2002)
  • K994073 — HEMOSITE TEST SYSTEM (January 14, 2000)
  • K992132 — CHOLESITE TEST SYSTEM (August 20, 1999)
  • K971145 — GLUCOSITE TEST SYSTEM (September 17, 1997)
  • K911801 — KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON (July 1, 1991)
  • K882038 — GDS ENZYMATIC SALICYLATE REAGENT (June 24, 1988)
  • K880829 — GDS ENZYMATIC ACETAMINOPHEN REAGENT (May 27, 1988)

Other clearances for product code KHG

  • K221508 — AnemoCheck Home (September 29, 2023)
  • K163215 — AnemoCheck (September 13, 2017)
  • K042379 — ANEMIAPRO SELF-SCREENER (December 15, 2004)
  • K020138 — STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARD (February 11, 2002)
  • K001462 — CARESIDE HEMOGLOBIN (August 21, 2000)
  • K994073 — HEMOSITE TEST SYSTEM (January 14, 2000)
  • K953221 — ABBOTT VISION HEMOGLOBIN (MODIFICATION) (September 29, 1995)
  • K934064 — REFLOTRON HEMOGLOBIN TEST TABS (December 6, 1993)
  • K895101 — BIOTRACK HEMOGLOBIN TEST CARTRIDGE (October 10, 1989)
  • K885227 — CLINISTAT HEMOGLOBIN REAGENT TEST (February 24, 1989)

FDA data resources