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510(k) K991800

HEMOCHEK URINE COLLECTION KIT by Osborn Group, Inc. — Product Code JIQ

K991800 is an FDA 510(k) premarket notification submitted by Osborn Group, Inc. for the device "HEMOCHEK URINE COLLECTION KIT". The FDA issued a decision of Substantially Equivalent on September 24, 1999. 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. Osborn Group, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1999
Date Received
May 26, 1999
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 Osborn Group, Inc.

  • K002156 — APPRAISE URINE MICROALBUMIN COLLECTION KIT (December 19, 2000)
  • K993787 — APPRAISE-CARDIO SAMPLE COLLECTION KIT (April 14, 2000)
  • K990899 — HEMOCHEK-A1C SAMPLE COLLECTION KIT (December 21, 1999)

Other clearances for product code JIQ

  • K141925 — TOTAL PROTEIN URINE/CSF GEN.3 (December 9, 2014)
  • K013643 — AUSAM TOTAL ALBUMIN ASSAY (August 14, 2003)
  • 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)
  • K935662 — SYNERMED IR 500 CHEMISTRY ANALYZER (April 26, 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