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510(k) K965103

WINMAX SOFTWARE SYSTEMS by Diagnostic Products Corp. — Product Code JJF

K965103 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "WINMAX SOFTWARE SYSTEMS". The FDA issued a decision of Substantially Equivalent on May 9, 1997. The device falls under product code JJF (Analyzer, Chemistry, Micro, For Clinical Use), a Class I device regulated under 21 CFR 862.2170. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1997
Date Received
December 20, 1996
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 Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 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)
  • K013654 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (June 5, 2002)
  • 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)

FDA data resources