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510(k) K895101

BIOTRACK HEMOGLOBIN TEST CARTRIDGE by Biotrack, Inc. — Product Code KHG

K895101 is an FDA 510(k) premarket notification submitted by Biotrack, Inc. for the device "BIOTRACK HEMOGLOBIN TEST CARTRIDGE". The FDA issued a decision of Substantially Equivalent on October 10, 1989. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Biotrack, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1989
Date Received
August 15, 1989
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 Biotrack, Inc.

  • K934062 — BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS (December 29, 1993)
  • K934061 — BIOTRACK VALPROIC ACID TEST CARTRIDGE (December 29, 1993)
  • K920525 — BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL (August 5, 1992)
  • K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGE (July 23, 1992)
  • K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGE (July 23, 1992)
  • K903924 — BIOTRACK THEOPHYLLINE QUALITY CONTROLS (September 17, 1990)
  • K900373 — BIOTRACK THEOPHYLLINE TEST CARTRIDGE (May 30, 1990)
  • K900372 — BIOTRACK IMMUNOCHEMISTRY MONITOR (February 23, 1990)
  • K895102 — BIOTRACK PDS MONITOR (October 10, 1989)
  • K895128 — BIOTRACK ALT TEST CARTRIDGE (October 6, 1989)

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)
  • K973649 — HEMOSITE TEST SYSTEM (August 31, 1998)
  • K953221 — ABBOTT VISION HEMOGLOBIN (MODIFICATION) (September 29, 1995)
  • K934064 — REFLOTRON HEMOGLOBIN TEST TABS (December 6, 1993)
  • K885227 — CLINISTAT HEMOGLOBIN REAGENT TEST (February 24, 1989)

FDA data resources