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510(k) K931559

DMA AMYLASE PROCEDURE by Data Medical Associates, Inc. — Product Code CIW

K931559 is an FDA 510(k) premarket notification submitted by Data Medical Associates, Inc. for the device "DMA AMYLASE PROCEDURE". The FDA issued a decision of Substantially Equivalent on October 28, 1993. The device falls under product code CIW (Starch-Dye Bound Polymer, 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
October 28, 1993
Date Received
March 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Starch-Dye Bound Polymer, 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)
  • K955796 — IRON CALIBRATOR & CALIBRATION VERIFICATION SET (February 29, 1996)
  • K955302 — SERUM BICARBONATE/CARBON DIOXIDE (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 CIW

  • K924339 — OLYMPUS AMYLASE REAGENT (October 19, 1992)
  • K884382 — AMYLASE TEST (AMYL) ITEM NUMBER: 65653 (January 11, 1989)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K812027 — KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) (August 3, 1981)
  • K810584 — PHADEBAS ISOAMYLASE TEST (May 13, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K782032 — UNITEST AMYLASE (March 2, 1979)

FDA data resources