Home / 510(k) Clearances / K821881

510(k) K821881

ULTRACHEM CREA by Harleco Diagnostics — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1982
Date Received
June 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Harleco Diagnostics

  • K823147 — URIC ACID STANDARD, 8MG/DL #65078 (November 22, 1982)
  • K822852 — TRIGLYCERIDE CALIBRATOR (October 27, 1982)
  • K822323 — ULTRACHEM BUN-UV, 65080 & 65081 (September 2, 1982)
  • K821871 — ULTRAZYME PLUS 2GT (July 14, 1982)
  • K821878 — ULTRAZYME PLUS LDH (July 14, 1982)
  • K821872 — ULTRACHEM URIC ACID AIDH (July 14, 1982)
  • K821882 — ULTRAZYME PLUS GPT (July 14, 1982)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
  • K821873 — ULTRACHEM T-BILI (July 14, 1982)

Other clearances for product code CGX

  • K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer (January 9, 2026)
  • K251058 — Tru Kidney Health Test Panel; Tru Analyzer (November 26, 2025)
  • K242685 — Atellica® CH Creatinine_3 (Crea3) (December 4, 2024)
  • K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer (November 19, 2024)
  • K210452 — Creatinine2 (March 22, 2022)
  • K161494 — Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (November 15, 2016)
  • K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE (January 27, 2014)
  • K133728 — DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE (January 24, 2014)
  • K123586 — EASYRA CREATININE REAGENT (May 15, 2013)
  • K110530 — ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PE (April 30, 2012)