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510(k) K023396

AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) by Pointe Scientific, Inc., — Product Code CIJ

K023396 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)". The FDA issued a decision of Substantially Equivalent on December 23, 2002. The device falls under product code CIJ (Saccharogenic, Amylase), a Class II device regulated under 21 CFR 862.1070. Pointe Scientific, Inc., has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2002
Date Received
October 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saccharogenic, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

Other clearances by Pointe Scientific, Inc.,

  • K070757 — MICROPROTEIN REAGENT SET (December 4, 2007)
  • K062118 — POINTE 360 (July 13, 2007)
  • K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT (April 30, 2007)
  • K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR (April 13, 2007)
  • K070504 — AMMONIA/ALCOHOL CONTROL SET (April 11, 2007)
  • K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (March 28, 2007)
  • K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (October 7, 2005)
  • K040391 — TOTAL BILIRUBIN REAGENT SET (June 2, 2004)
  • K031539 — HEMOGLOBIN A1C REAGENT SET (August 6, 2003)
  • K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS (April 28, 2003)

Other clearances for product code CIJ

  • K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (July 22, 1999)
  • K980013 — AMYLASE (February 4, 1998)
  • K953211 — AMYLASE (ETHYLIDENE PNGPG7) KIT (June 21, 1996)
  • K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (December 11, 1995)
  • K940735 — LIQUID AMYLASE (CNPG3) REAGENT SET (August 1, 1994)
  • K940010 — DMA AMYLASE (DEMAND) PROCEDURE (March 11, 1994)
  • K931301 — OLYMPUS AMYLASE REAGENT (October 18, 1993)
  • K931141 — BIOTROL AMYLASE CNPG3 (May 26, 1993)
  • K882225 — -AMYLASE EPS (January 3, 1989)
  • K873250 — ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL (October 20, 1987)

FDA data resources