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510(k) K801268

HEMOGLOBIN CONTROL LEVELS by Bioscientific — Product Code KHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1980
Date Received
May 28, 1980
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 Bioscientific

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  • K811251 — CITRATE BUFFER (May 21, 1981)
  • K801265 — WHITE BLOOD CELL COUNT CONTROL LEVELS (July 14, 1980)
  • K801267 — RED BLOOD CELL COUNT & HEMATOCRIT CNTL (July 14, 1980)
  • K791658 — WRIGHT STAIN PACK (October 17, 1979)
  • K791007 — STAT DIFF STAIN (August 3, 1979)
  • K790415 — HCP-7 (April 4, 1979)
  • K781734 — SODIUM CHLORIDE, 0.85% (October 24, 1978)
  • K781582 — PAPANICOLAOU STAIN EA-36 (October 10, 1978)
  • K781585 — HEMATOXYLIN STAIN HARRIS (October 10, 1978)

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)
  • K895101 — BIOTRACK HEMOGLOBIN TEST CARTRIDGE (October 10, 1989)