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510(k) K892393

ACID PHOSPHATASE REAGENT by Medical Analysis Systems, Inc. — Product Code CKB

K892393 is an FDA 510(k) premarket notification submitted by Medical Analysis Systems, Inc. for the device "ACID PHOSPHATASE REAGENT". The FDA issued a decision of Substantially Equivalent on July 20, 1989. The device falls under product code CKB (Acid Phosphatase, Naphthyl Phosphate), a Class II device regulated under 21 CFR 862.1020. Medical Analysis Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1989
Date Received
April 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Naphthyl Phosphate
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type

Other clearances by Medical Analysis Systems, Inc.

  • K042717 — MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL (November 5, 2004)
  • K041194 — ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, (August 16, 2004)
  • K040880 — MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (April 28, 2004)
  • K032826 — MAS PAR TDM (October 9, 2003)
  • K032335 — MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL (August 19, 2003)
  • K031890 — MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL (July 16, 2003)
  • K031392 — MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (July 1, 2003)
  • K031441 — URICHEMTRAK LIQUID ASSAYED URINE CONTROL (July 1, 2003)
  • K031364 — MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 (May 30, 2003)
  • K030942 — MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL (April 28, 2003)

Other clearances for product code CKB

  • K053612 — DRI-STAT ACID PHOSPHATASE REAGENT (April 26, 2006)
  • K023840 — ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (January 7, 2003)
  • K991010 — ACP (May 19, 1999)
  • K981743 — OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (June 9, 1998)
  • K974695 — COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES W (May 21, 1998)
  • K963640 — OLYMPUS ACID PHOSPHATASE REAGENT (February 18, 1997)
  • K943366 — IL TEST ACID PHOSPHATASE (January 29, 1996)
  • K902543 — ACID PHOSPHOTASE REAGENT TEST AND KIT (September 7, 1990)
  • K902495 — ACID PHOSPHATASE REAGENT SET (July 16, 1990)
  • K884747 — TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) (January 30, 1989)

FDA data resources