Home / 510(k) Clearances / K820975

510(k) K820975

GILCHEM ACID PHOSPHATASE REAGENT by Gilford Diagnostics — Product Code CKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1982
Date Received
April 6, 1982
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 Gilford Diagnostics

  • K832094 — BILIRUBIN CALIBRATORS & CONTROL (August 11, 1983)
  • K831843 — GILCHEM TOTAL BILIRUBIN REAGENT (July 18, 1983)
  • K831844 — DIRECT BILIRUBIN REAGENT (July 18, 1983)
  • K823709 — TRIGLYCERIDE REAGENT (UV) (January 7, 1983)
  • K822739 — AHBD (October 18, 1982)
  • K822334 — BILIRUBIN CALIBRATORS (September 2, 1982)
  • K822289 — CO2/CI STANDARDS (August 24, 1982)
  • K822149 — GILCHEM Y-GT REAGENT (August 12, 1982)
  • K821719 — AMMONIA REAGENT (June 24, 1982)
  • K820976 — GIL CHEM MAGNESIUM REAGENT (April 26, 1982)

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)