FDA 510(k)

COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922

K-Number: K003278 · 2001-01-17

ApplicantIrvine Scientific Sales Co., Inc.

Decision Date2001-01-17

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific Sales Co., Inc.. It received FDA 510(k) clearance on 2001-01-17 under 510(k) number K003278. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922?

COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 is a medical device that received FDA 510(k) clearance on 2001-01-17. The listed applicant is Irvine Scientific Sales Co., Inc.. The 510(k) number is K003278.

When did COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 receive FDA 510(k) clearance?

COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 received FDA 510(k) clearance on 2001-01-17, under 510(k) number K003278.

Who is the listed applicant for COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922?

The FDA 510(k) record lists Irvine Scientific Sales Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922?

The FDA product code for COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 is MQL.

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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.