Home / 510(k) Clearances / K832115

510(k) K832115

ATAC 3000 by Turpen Laboratory Systems, Inc. — Product Code JJE

K832115 is an FDA 510(k) premarket notification submitted by Turpen Laboratory Systems, Inc. for the device "ATAC 3000". The FDA issued a decision of Substantially Equivalent on January 10, 1984. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Turpen Laboratory Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1984
Date Received
June 30, 1983
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 Turpen Laboratory Systems, Inc.

  • K870836 — ATAC 1500 CHEMISTRY ANALYZER (April 1, 1987)
  • K863332 — ATAC 4300 HEMATOLOGY CELL COUNTER (September 29, 1986)
  • K851321 — ATAC 2000 CHEMISTRY ANALYZER (April 25, 1985)
  • K843059 — ATAC 2000 (October 11, 1984)
  • K832116 — ATAC 4700 HEMATOLOGY CELL COUNTER (October 20, 1983)

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)

FDA data resources