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510(k) K003030

LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET by Bio-Rad — Product Code GGM

K003030 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET". The FDA issued a decision of Substantially Equivalent on November 29, 2000. The device falls under product code GGM (Control, Hemoglobin), a Class II device regulated under 21 CFR 864.8625. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2000
Date Received
September 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hemoglobin
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

Other clearances for product code GGM

  • K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (November 15, 2019)
  • K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (February 1, 2019)
  • K070546 — LYPHOCHEK DIABETES CONTROL (April 2, 2007)
  • K070334 — R&D SICKLE QC CONTROL (March 29, 2007)
  • K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (November 9, 2005)
  • K032791 — GLYCOHEMOSURE HBA1C CONTROL (October 30, 2003)
  • K993321 — R&D HGB/GLC WHOLE BLOOD CONTROL (November 12, 1999)
  • K964052 — HEMOCUE HEMOTROL (November 6, 1996)
  • K963908 — HEMOCUE HEMOLIN (October 16, 1996)
  • K921681 — CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL (November 17, 1992)

FDA data resources