Intersect Systems' Non-Mercuric Chloride Reagent

Q: What is the product code of K941807?

The FDA product code is CHG – Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.

FDA 510(k) K941807 · Intersect Systems, Inc.

Substantially Equivalent

510(k) numberK941807

Submission

Device name: Intersect Systems' Non-Mercuric Chloride Reagent
Applicant: Intersect Systems, Inc.
Longview, WA, US
Received: April 12, 1994
Decision date: September 14, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: CHG – Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1170
Specialty: Clinical Chemistry

Other 510(k)s with product code CHG

510(k)	Device	Applicant	Decision
K934588	Chloride (MF) AssayCHG · Traditional	Diagnostic Chemicals , Ltd.	02/18/1994SE
K903103	Synermed Chloride Reagent KitCHG · Traditional	Synermed, Inc.	08/09/1990SE

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K932267	Enzymatic CO2 Reagent, ModificationKHS · Traditional	09/24/1993SE
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Questions and answers

When was Intersect Systems' Non-Mercuric Chloride Reagent cleared by the FDA?

Intersect Systems' Non-Mercuric Chloride Reagent (K941807) received a 510(k) decision of Substantially Equivalent on September 14, 1994, 155 days after the submission was received.

What is the product code of K941807?

The FDA product code is CHG – Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.