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510(k) K940735

LIQUID AMYLASE (CNPG3) REAGENT SET by Pointe Scientific, Inc., — Product Code CIJ

K940735 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "LIQUID AMYLASE (CNPG3) REAGENT SET". The FDA issued a decision of Substantially Equivalent on Aug 1, 1994. 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
Aug 1, 1994
Date Received
Feb 17, 1994
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 (Dec 4, 2007)
  • K062118 — POINTE 360 (Jul 13, 2007)
  • K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT (Apr 30, 2007)
  • K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR (Apr 13, 2007)
  • K070504 — AMMONIA/ALCOHOL CONTROL SET (Apr 11, 2007)
  • K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (Mar 28, 2007)
  • K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (Oct 7, 2005)
  • K040391 — TOTAL BILIRUBIN REAGENT SET (Jun 2, 2004)
  • K031539 — HEMOGLOBIN A1C REAGENT SET (Aug 6, 2003)
  • K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS (Apr 28, 2003)

Other clearances for product code CIJ

  • K023396 — AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) (Dec 23, 2002)
  • K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (Jul 22, 1999)
  • K980013 — AMYLASE (Feb 4, 1998)
  • K953211 — AMYLASE (ETHYLIDENE PNGPG7) KIT (Jun 21, 1996)
  • K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (Dec 11, 1995)
  • K940010 — DMA AMYLASE (DEMAND) PROCEDURE (Mar 11, 1994)
  • K931301 — OLYMPUS AMYLASE REAGENT (Oct 18, 1993)
  • K931141 — BIOTROL AMYLASE CNPG3 (May 26, 1993)
  • K882225 — -AMYLASE EPS (Jan 3, 1989)
  • K873572 — IL 35260, IL TEST AMYLASE REAGENT (Oct 20, 1987)

FDA data resources