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510(k) K941807

INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT by Intersect Systems, Inc. — Product Code CHG

K941807 is an FDA 510(k) premarket notification submitted by Intersect Systems, Inc. for the device "INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT". The FDA issued a decision of Substantially Equivalent on September 14, 1994. The device falls under product code CHG (Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride), a Class II device regulated under 21 CFR 862.1170. Intersect Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1994
Date Received
April 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

Other clearances by Intersect Systems, Inc.

  • K021636 — ALBUMIN REAGENT (July 17, 2002)
  • K011972 — DIRECT BILIRUBIN REAGENT (August 27, 2001)
  • K011692 — HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (July 25, 2001)
  • K003892 — TOTAL BILIRUBIN REAGENT (February 20, 2001)
  • K983937 — DUAL VIAL CREATININE REAGENT (January 6, 1999)
  • K974833 — CK-NAC REAGENT (February 13, 1998)
  • K932888 — INTERSECT SYSTEMS DIRECT AMYLASE REAGENT (January 31, 1994)
  • K934039 — INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET (November 16, 1993)
  • K932267 — ENZYMATIC CO2 REAGENT, MODIFICATION (September 24, 1993)
  • K913225 — URINE/CSF MICROPROTEIN REAGENT (October 11, 1991)

Other clearances for product code CHG

  • K934588 — CHLORIDE (MF) ASSAY (February 18, 1994)
  • K903103 — SYNERMED CHLORIDE REAGENT KIT (August 9, 1990)

FDA data resources