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510(k) K896168

HEMOGLOBIN A2 MICRO COLUMN TEST by Bio-Rad — Product Code JPD

K896168 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "HEMOGLOBIN A2 MICRO COLUMN TEST". The FDA issued a decision of Substantially Equivalent on January 18, 1990. The device falls under product code JPD (Hemoglobin A2 Quantitation), a Class II device regulated under 21 CFR 864.7400. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1990
Date Received
October 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A2 Quantitation
Device Class
Class II
Regulation Number
864.7400
Review Panel
HE
Submission Type

Other clearances by Bio-Rad

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  • 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 JPD

  • K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (May 14, 2002)
  • K991127 — VARIANT II B-THALASSEMIA (June 10, 1999)
  • K924122 — VARIANT BETA-THALASSEMIA SHORT PROGRAM (March 11, 1993)
  • K924496 — GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT (November 16, 1992)
  • K923317 — COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL (August 25, 1992)
  • K923318 — COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL (August 25, 1992)
  • K913384 — COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 (December 17, 1991)
  • K875102 — DETER. OF HEMOGLOBIN A2 USING THE DIAMAT (February 24, 1988)
  • K823870 — BETA THALQUIK COLUMN #5341 (February 1, 1983)
  • K812077 — HELENA SICKLE-THAL QUIK COLUMN METHOD (August 18, 1981)

FDA data resources