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FDA 510(k)

DIAGEM 300 BG REAGENT STRIPS

K-Number: K854329 · 1986-08-04

ApplicantSeton Products, Inc.
Decision Date1986-08-04
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAGEM 300 BG REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Seton Products, Inc.. It received FDA 510(k) clearance on 1986-08-04 under 510(k) number K854329. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGEM 300 BG REAGENT STRIPS?

DIAGEM 300 BG REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1986-08-04. The listed applicant is Seton Products, Inc.. The 510(k) number is K854329.

When did DIAGEM 300 BG REAGENT STRIPS receive FDA 510(k) clearance?

DIAGEM 300 BG REAGENT STRIPS received FDA 510(k) clearance on 1986-08-04, under 510(k) number K854329.

Who is the listed applicant for DIAGEM 300 BG REAGENT STRIPS?

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

What is the FDA product code for DIAGEM 300 BG REAGENT STRIPS?

The FDA product code for DIAGEM 300 BG REAGENT STRIPS is CGA.

Related Clinical Trials

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.

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Other records listing Seton Products, 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.

K840617MASTERFOOT CAST HEEL

Related Devices (Code: CGA)

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.

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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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