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510(k) K790524

DATA-ZYME ACIA PHOSPHATASE PROCEDURE by Data Medical Associates, Inc. — Product Code CKE

K790524 is an FDA 510(k) premarket notification submitted by Data Medical Associates, Inc. for the device "DATA-ZYME ACIA PHOSPHATASE PROCEDURE". The FDA issued a decision of Substantially Equivalent on May 23, 1979. The device falls under product code CKE (Acid Phosphatase, Thymolphthale Inmonophosphate), a Class II device regulated under 21 CFR 862.1020. Data Medical Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1979
Date Received
March 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Thymolphthale Inmonophosphate
Device Class
Class II
Regulation Number
862.1020
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 CKE

  • K914167 — CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE (March 17, 1992)
  • K915705 — ACID PHOSPHATASE REAGENT SET (February 27, 1992)
  • K873726 — ACID PHOSPHATASE TEST (January 27, 1988)
  • K864230 — DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM (November 28, 1986)
  • K860476 — ACID PHOSPHATASE REAGENT SET (March 5, 1986)
  • K843380 — ACID PHOSPHATASE ASSAY KIT (September 20, 1984)
  • K821526 — ACID PHOSPHATASE REAGENT SET (June 10, 1982)
  • K800693 — STANBIO PROSTATIC ACID PHOSPHATASE TEST (April 16, 1980)

FDA data resources