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510(k) K854223

VES-TEC/VES-MATIC by Marvic Interpharma, Inc. — Product Code CKB

K854223 is an FDA 510(k) premarket notification submitted by Marvic Interpharma, Inc. for the device "VES-TEC/VES-MATIC". The FDA issued a decision of Substantially Equivalent on April 4, 1986. The device falls under product code CKB (Acid Phosphatase, Naphthyl Phosphate), a Class II device regulated under 21 CFR 862.1020. Marvic Interpharma, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1986
Date Received
October 18, 1985
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 Marvic Interpharma, Inc.

  • K854222 — DIESSE RF TEST KIT (February 6, 1986)
  • K854221 — DIESSE CRP TEST KIT (November 25, 1985)

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)
  • K892393 — ACID PHOSPHATASE REAGENT (July 20, 1989)

FDA data resources