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FDA 510(k)

GOOD MORNING TEST

K-Number: K031798 · 2003-11-12

ApplicantStandard Diagnostics, Inc.
Decision Date2003-11-12
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GOOD MORNING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Standard Diagnostics, Inc.. It received FDA 510(k) clearance on 2003-11-12 under 510(k) number K031798. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOOD MORNING TEST?

GOOD MORNING TEST is a medical device that received FDA 510(k) clearance on 2003-11-12. The listed applicant is Standard Diagnostics, Inc.. The 510(k) number is K031798.

When did GOOD MORNING TEST receive FDA 510(k) clearance?

GOOD MORNING TEST received FDA 510(k) clearance on 2003-11-12, under 510(k) number K031798.

Who is the listed applicant for GOOD MORNING TEST?

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

What is the FDA product code for GOOD MORNING TEST?

The FDA product code for GOOD MORNING TEST is LCX.

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Other records listing Standard Diagnostics, Inc. as applicant

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Official Source

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

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