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510(k) K935662

SYNERMED IR 500 CHEMISTRY ANALYZER by Synermed, Inc. — Product Code JIQ

K935662 is an FDA 510(k) premarket notification submitted by Synermed, Inc. for the device "SYNERMED IR 500 CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on April 26, 1994. The device falls under product code JIQ (Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. Synermed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1994
Date Received
November 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1645
Review Panel
CH
Submission Type

Other clearances by Synermed, Inc.

  • K973109 — SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT (September 25, 1997)
  • K972716 — SYNERMED TOTAL BILIRUBIN REAGENT KIT (August 7, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)
  • K962479 — SYNERMED ISE REAGENTS (March 3, 1997)
  • K963939 — SYNERMED DIRECT BILIRUBIN REAGENT KIT (December 18, 1996)
  • K960793 — SYNERMED ENZYMATIC CO2 REAGENT KIT (March 11, 1996)
  • K953395 — SYNERMED CALCIUM REAGENT KIT (August 31, 1995)
  • K952179 — SYNERMED ISE REAGENTS (June 20, 1995)
  • K943924 — CREATININE-PO REAGENT KIT (September 20, 1994)
  • K941091 — SYNERMED AMYLASE REAGENT KIT (May 3, 1994)

Other clearances for product code JIQ

  • K141925 — TOTAL PROTEIN URINE/CSF GEN.3 (December 9, 2014)
  • K013643 — AUSAM TOTAL ALBUMIN ASSAY (August 14, 2003)
  • K991800 — HEMOCHEK URINE COLLECTION KIT (September 24, 1999)
  • K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (September 2, 1997)
  • K965035 — IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT (April 17, 1997)
  • K944664 — WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR (February 7, 1995)
  • K936202 — URINARY ALBUMIN TEST PACK (May 9, 1994)
  • K903123 — RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT (September 14, 1990)
  • K902216 — WAKO(TM) MICRO-ALBUMIN (June 18, 1990)
  • K895883 — BECKMAN MA MICROALBUMIN REAGENT KIT (December 27, 1989)

FDA data resources