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510(k) K944255

DMA CALCIUM PLUS PROCEDURE by Data Medical Associates, Inc. — Product Code CJY

K944255 is an FDA 510(k) premarket notification submitted by Data Medical Associates, Inc. for the device "DMA CALCIUM PLUS PROCEDURE". The FDA issued a decision of Substantially Equivalent on December 6, 1994. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Data Medical Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1994
Date Received
September 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
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 CJY

  • K244042 — Calcium2 (February 10, 2025)
  • K191396 — Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (July 26, 2019)
  • K182042 — Randox Calcium (Ca) (October 23, 2018)
  • K151113 — ELITech Clinical Systems CALCIUM ARSENAZO (July 22, 2015)
  • K123171 — ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX (July 3, 2013)
  • K120626 — EON CALCIUM REGENT (August 22, 2012)
  • K083386 — ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 0 (April 2, 2009)
  • K072356 — S-TEST CA (June 24, 2008)
  • K073355 — CALCIUM, SCAL, NORTROL, ABTROL (February 28, 2008)
  • K072443 — VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (September 24, 2007)

FDA data resources