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510(k) K042379

ANEMIAPRO SELF-SCREENER by Biosafe Laboratories, Inc. — Product Code KHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2004
Date Received
September 1, 2004
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 Biosafe Laboratories, Inc.

  • K012221 — SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (April 3, 2002)
  • K011970 — BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (September 26, 2001)
  • K011525 — SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYS (July 16, 2001)
  • K003752 — BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (March 23, 2001)
  • K991850 — SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC (November 26, 1999)

Other clearances for product code KHG

  • K221508 — AnemoCheck Home (September 29, 2023)
  • K163215 — AnemoCheck (September 13, 2017)
  • 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)
  • K895101 — BIOTRACK HEMOGLOBIN TEST CARTRIDGE (October 10, 1989)
  • K885227 — CLINISTAT HEMOGLOBIN REAGENT TEST (February 24, 1989)