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510(k) K940010

DMA AMYLASE (DEMAND) PROCEDURE by Data Medical Associates, Inc. — Product Code CIJ

K940010 is an FDA 510(k) premarket notification submitted by Data Medical Associates, Inc. for the device "DMA AMYLASE (DEMAND) PROCEDURE". The FDA issued a decision of Substantially Equivalent on March 11, 1994. The device falls under product code CIJ (Saccharogenic, Amylase), a Class II device regulated under 21 CFR 862.1070. Data Medical Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
January 4, 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 Data Medical Associates, Inc.

  • K993098 — HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 (October 8, 1999)
  • K971113 — DMA TRIGLYCERIDES PROCEDURES (May 29, 1997)
  • K961919 — DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE (July 1, 1996)
  • K955302 — SERUM BICARBONATE/CARBON DIOXIDE (February 29, 1996)
  • K955796 — IRON CALIBRATOR & CALIBRATION VERIFICATION SET (February 29, 1996)
  • K955300 — TOTAL BILIRUBIN PROCEDURE (December 20, 1995)
  • K952437 — DMA GLUCOSE HEXOKINASE U.V. PROCEDURE (October 3, 1995)
  • K946161 — DMA TOTAL CHOLESTEROL PROCEDURE (August 23, 1995)
  • K946354 — DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE (May 8, 1995)
  • K946355 — DMA ALBUMIN PROCEDURE (March 1, 1995)

Other clearances for product code CIJ

  • K023396 — AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) (December 23, 2002)
  • 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)
  • 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