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FDA 510(k)

INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT

K-Number: K941807 · 1994-09-14

ApplicantIntersect Systems, Inc.
Decision Date1994-09-14
Product CodeCHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 1994-09-14 under 510(k) number K941807. The device is classified under product code CHG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT?

INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT is a medical device that received FDA 510(k) clearance on 1994-09-14. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K941807.

When did INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT receive FDA 510(k) clearance?

INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT received FDA 510(k) clearance on 1994-09-14, under 510(k) number K941807.

Who is the listed applicant for INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT?

The FDA 510(k) record lists Intersect Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT?

The FDA product code for INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT is CHG.

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Other records listing Intersect Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021636ALBUMIN REAGENTK011972DIRECT BILIRUBIN REAGENTK011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENTK003892TOTAL BILIRUBIN REAGENTK983937DUAL VIAL CREATININE REAGENTK974833CK-NAC REAGENT

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Related Devices (Code: CHG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934588CHLORIDE (MF) ASSAYDiagnostic Chemicals , Ltd.K903103SYNERMED CHLORIDE REAGENT KITSynermed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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