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510(k) K823870

BETA THALQUIK COLUMN #5341 by Helena Laboratories — Product Code JPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1983
Date Received
December 23, 1982
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

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  • 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)
  • K812077 — HELENA SICKLE-THAL QUIK COLUMN METHOD (August 18, 1981)