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FDA 510(k)

IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST

K-Number: K121231 · 2012-07-30

ApplicantInd Ndiagnostic, Inc.
Decision Date2012-07-30
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ind Ndiagnostic, Inc.. It received FDA 510(k) clearance on 2012-07-30 under 510(k) number K121231. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST?

IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST is a medical device that received FDA 510(k) clearance on 2012-07-30. The listed applicant is Ind Ndiagnostic, Inc.. The 510(k) number is K121231.

When did IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST receive FDA 510(k) clearance?

IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST received FDA 510(k) clearance on 2012-07-30, under 510(k) number K121231.

Who is the listed applicant for IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST?

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

What is the FDA product code for IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST?

The FDA product code for IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST is NGT.

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Official Source

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