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510(k) K221508

AnemoCheck Home by Sanguina, Inc. — Product Code KHG

K221508 is an FDA 510(k) premarket notification submitted by Sanguina, Inc. for the device "AnemoCheck Home". The FDA issued a decision of Substantially Equivalent on September 29, 2023. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Sanguina, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2023
Date Received
May 24, 2022
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 Sanguina, Inc.

  • K163215 — AnemoCheck (September 13, 2017)

Other clearances for product code KHG

  • 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)
  • K895101 — BIOTRACK HEMOGLOBIN TEST CARTRIDGE (October 10, 1989)
  • K885227 — CLINISTAT HEMOGLOBIN REAGENT TEST (February 24, 1989)

FDA data resources