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510(k) K013654

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER by Precision Systems, Inc. — Product Code JJF

K013654 is an FDA 510(k) premarket notification submitted by Precision Systems, Inc. for the device "PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on June 5, 2002. The device falls under product code JJF (Analyzer, Chemistry, Micro, For Clinical Use), a Class I device regulated under 21 CFR 862.2170. Precision Systems, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2002
Date Received
November 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Device Class
Class I
Regulation Number
862.2170
Review Panel
CH
Submission Type

Other clearances by Precision Systems, Inc.

  • K024182 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS (March 3, 2003)
  • K022072 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENT (August 23, 2002)

Other clearances for product code JJF

  • K052794 — ETI-MAX 3000 (March 31, 2006)
  • K040332 — POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER (June 16, 2004)
  • K033734 — LIGHTCYCLER INSTRUMENT VERSION 1.2 (December 17, 2003)
  • K012966 — ROCHE COBAS TAQMAN ANALYZER (February 1, 2002)
  • K993634 — CARESIDE ANALYZER (December 2, 1999)
  • K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (March 13, 1998)
  • K980056 — CARESIDE ANALYZER (March 6, 1998)
  • K973177 — MAGO AUTOMATED EIA PROCESSOR (October 9, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)
  • K964506 — ROCHE COBAS AMPLICOR ANALYZER (May 21, 1997)

FDA data resources