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510(k) K851321

ATAC 2000 CHEMISTRY ANALYZER by Turpen Laboratory Systems, Inc. — Product Code JQP

K851321 is an FDA 510(k) premarket notification submitted by Turpen Laboratory Systems, Inc. for the device "ATAC 2000 CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on April 25, 1985. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Turpen Laboratory Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1985
Date Received
April 2, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
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)
  • K843059 — ATAC 2000 (October 11, 1984)
  • K832115 — ATAC 3000 (January 10, 1984)
  • K832116 — ATAC 4700 HEMATOLOGY CELL COUNTER (October 20, 1983)

Other clearances for product code JQP

  • K113007 — BIONIME DIABETES MANAGEMENT SYSTEM VI.0 (February 27, 2012)
  • K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (December 17, 1998)
  • K964460 — THE ROBOLITE (January 24, 1997)
  • K953652 — PRENVAL I (September 15, 1995)
  • K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS) (November 2, 1994)
  • K923316 — EXPRESSO CARTRIDGE (February 23, 1993)
  • K893838 — MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (August 31, 1989)
  • K892060 — CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (August 10, 1989)
  • K885292 — COBAS MFC (March 22, 1989)
  • K881194 — RIA-QUICK (June 1, 1988)

FDA data resources