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510(k) K895718

LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER by Data Medical Associates, Inc. — Product Code JGM

K895718 is an FDA 510(k) premarket notification submitted by Data Medical Associates, Inc. for the device "LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER". The FDA issued a decision of Substantially Equivalent on October 19, 1989. The device falls under product code JGM (Flame Photometry, Potassium), a Class II device regulated under 21 CFR 862.1600. Data Medical Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1989
Date Received
September 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Potassium
Device Class
Class II
Regulation Number
862.1600
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 JGM

  • K862300 — AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT (July 29, 1986)
  • K831300 — MSI-NAK-50 TEST KIT (July 18, 1983)
  • K810253 — SODIUM & POTASSIUM TEST KIT (February 10, 1981)
  • K771068 — TRIGLYCERIDE KIT (July 12, 1977)

FDA data resources