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510(k) K872891

LACTATE DEHYDROGENASE ISOENZYME 1 by Data Medical Associates, Inc. — Product Code CEX

K872891 is an FDA 510(k) premarket notification submitted by Data Medical Associates, Inc. for the device "LACTATE DEHYDROGENASE ISOENZYME 1". The FDA issued a decision of Substantially Equivalent on September 16, 1987. The device falls under product code CEX (Chromatographic Separation, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Data Medical Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1987
Date Received
July 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
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 CEX

  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 1985)
  • K842018 — ISO-SEP SYSTEM (September 28, 1984)
  • K821983 — TITAN GEL LDH ISOENZYME KIT (December 22, 1982)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K800129 — CENTRIFICHEM CREATININE (February 13, 1980)
  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)
  • K771894 — LDH ISOENZYME CONTROL (December 22, 1977)

FDA data resources