Home / 510(k) Clearances / K945271

510(k) K945271

ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM by Bio-Chem Laboratory Systems, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1995
Date Received
October 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

Other clearances by Bio-Chem Laboratory Systems, Inc.

  • K930689 — AUTOBEAD THYROID UPTAKE (November 10, 1993)
  • K930006 — AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (September 9, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K924084 — ATAC 6000 CHEMISTRY ANALYZER (September 29, 1992)

Other clearances for product code JJE

  • K183375 — Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, (February 12, 2019)
  • K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMIS (May 16, 2014)
  • K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK (May 15, 2014)
  • K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE ( (January 9, 2014)
  • K130276 — DIMENSION EXL WITH LM SYSTEM (March 22, 2013)
  • K113253 — ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGEN (May 17, 2012)
  • K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEM (November 22, 2011)
  • K110035 — INDIKO (June 28, 2011)
  • K073370 — TC MATRIX CLINICAL CHEMISTRY ANALYZER (May 8, 2008)
  • K063144 — VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (November 13, 2006)