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510(k) K853699

EASY ANALYZER & EASY-TEST REAGENT by Diagnostic Systems — Product Code JJE

K853699 is an FDA 510(k) premarket notification submitted by Diagnostic Systems for the device "EASY ANALYZER & EASY-TEST REAGENT". The FDA issued a decision of Substantially Equivalent on September 25, 1985. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1985
Date Received
September 4, 1985
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 Diagnostic Systems

  • K905146 — OLYMPUS URINE PH (February 4, 1991)
  • K893691 — EMDS CREATINE KINASE ITEM NIMBER 65411 (August 31, 1989)
  • K893692 — EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 (August 21, 1989)
  • K893966 — HDL PRECIPITATING REAGENT (July 25, 1989)
  • K884993 — VISUAL BLOOD GLUCOSE TEST SYSTEM (December 29, 1988)
  • K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (June 20, 1988)
  • K880787 — EASY-TEST LACTIC ACID (LA) (March 15, 1988)
  • K862403 — EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 (July 11, 1986)
  • K854784 — ABSORBANCE (ABS) TEST PAK (December 19, 1985)
  • K853533 — ABSORBANCE TEST SOLUTION (September 16, 1985)

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