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510(k) K831623

DIA STRIPS SYSTEM by California Immuno Diagnostic, Inc. — Product Code CDM

K831623 is an FDA 510(k) premarket notification submitted by California Immuno Diagnostic, Inc. for the device "DIA STRIPS SYSTEM". The FDA issued a decision of Substantially Equivalent on July 28, 1983. The device falls under product code CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1785. California Immuno Diagnostic, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1983
Date Received
May 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1785
Review Panel
CH
Submission Type

Other clearances by California Immuno Diagnostic, Inc.

  • K823445 — ALKPHOR SYSTEM (December 28, 1982)
  • K800698 — AUTOFLUOR SYSTEM (May 28, 1980)

Other clearances for product code CDM

  • K052719 — URITEST 10 URINALYSIS REAGENT STRIPS (December 5, 2006)
  • K061559 — ACON URINALYSIS REAGENT STRIPS (August 11, 2006)
  • K880584 — URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C (May 31, 1988)
  • K873366 — WAKO(TM) PRETEST 5A (January 21, 1988)
  • K852611 — TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE (September 3, 1985)
  • K830340 — FITKIT I CHECKUP KIT (August 16, 1983)
  • K821799 — FITKIT I CHECKUP KIT (August 16, 1983)
  • K790965 — REAGENT STRIPS FOR URINALYSIS (June 28, 1979)

FDA data resources