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510(k) K020138

STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 by Gds Technology — Product Code KHG

K020138 is an FDA 510(k) premarket notification submitted by Gds Technology for the device "STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090". The FDA issued a decision of Substantially Equivalent on February 11, 2002. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Gds Technology has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2002
Date Received
January 16, 2002
Clearance Type
Special
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

  • K994073 — HEMOSITE TEST SYSTEM (January 14, 2000)
  • K992132 — CHOLESITE TEST SYSTEM (August 20, 1999)
  • K973649 — HEMOSITE TEST SYSTEM (August 31, 1998)
  • 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)
  • K001462 — CARESIDE HEMOGLOBIN (August 21, 2000)
  • K994073 — HEMOSITE TEST SYSTEM (January 14, 2000)
  • K973649 — HEMOSITE TEST SYSTEM (August 31, 1998)
  • 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