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510(k) K803108

HELENA HBA2 QUIK COLUMN METHOD by Helena Laboratories — Product Code JPD

K803108 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "HELENA HBA2 QUIK COLUMN METHOD". The FDA issued a decision of Substantially Equivalent on January 9, 1981. The device falls under product code JPD (Hemoglobin A2 Quantitation), a Class II device regulated under 21 CFR 864.7400. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1981
Date Received
December 10, 1980
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 Helena Laboratories

  • K213396 — SPIFE A1AT kit (October 13, 2022)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

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)
  • K923318 — COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL (August 25, 1992)
  • K923317 — COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL (August 25, 1992)
  • K913384 — COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 (December 17, 1991)
  • K896168 — HEMOGLOBIN A2 MICRO COLUMN TEST (January 18, 1990)
  • K875102 — DETER. OF HEMOGLOBIN A2 USING THE DIAMAT (February 24, 1988)
  • K823870 — BETA THALQUIK COLUMN #5341 (February 1, 1983)

FDA data resources