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FDA 510(k)

ENTERO-TEST HP, MODEL #102-01

K-Number: K983119 · 1999-03-15

ApplicantHdc Corp.
Decision Date1999-03-15
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENTERO-TEST HP, MODEL #102-01 is the device name listed in this FDA 510(k) record. The listed applicant is Hdc Corp.. It received FDA 510(k) clearance on 1999-03-15 under 510(k) number K983119. The device is classified under product code LIO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERO-TEST HP, MODEL #102-01?

ENTERO-TEST HP, MODEL #102-01 is a medical device that received FDA 510(k) clearance on 1999-03-15. The listed applicant is Hdc Corp.. The 510(k) number is K983119.

When did ENTERO-TEST HP, MODEL #102-01 receive FDA 510(k) clearance?

ENTERO-TEST HP, MODEL #102-01 received FDA 510(k) clearance on 1999-03-15, under 510(k) number K983119.

Who is the listed applicant for ENTERO-TEST HP, MODEL #102-01?

The FDA 510(k) record lists Hdc Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTERO-TEST HP, MODEL #102-01?

The FDA product code for ENTERO-TEST HP, MODEL #102-01 is LIO.

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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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