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510(k) K924496

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT by Drew Scientific , Ltd. — Product Code JPD

K924496 is an FDA 510(k) premarket notification submitted by Drew Scientific , Ltd. for the device "GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT". The FDA issued a decision of Substantially Equivalent on November 16, 1992. The device falls under product code JPD (Hemoglobin A2 Quantitation), a Class II device regulated under 21 CFR 864.7400. Drew Scientific , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1992
Date Received
September 4, 1992
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 Drew Scientific , Ltd.

  • K071562 — D3 HEMATOLOGY ANALYZER, MODEL D3 (December 11, 2007)
  • K070704 — TRILOGY ANALYZER (July 13, 2007)
  • K060510 — DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT (June 19, 2006)
  • K043378 — DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT (December 29, 2004)
  • K012152 — DS30 HCY BLOOD COLLECTION TUBES (September 18, 2001)
  • K982003 — DS30 HCY HOMOCYSTEINE ASSAY KIT (February 11, 1999)
  • K933287 — 745 GLYCOMAT (September 9, 1993)
  • K920198 — GLYCOMAT HAEMOGLOBIN ANALYSER (July 21, 1992)

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

FDA data resources