FDA 510(k)

QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET

K-Number: K961912 · 1996-08-15

ApplicantConsolidated Technologies, Inc.

Decision Date1996-08-15

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Technologies, Inc.. It received FDA 510(k) clearance on 1996-08-15 under 510(k) number K961912. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET?

QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Consolidated Technologies, Inc.. The 510(k) number is K961912.

When did QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET receive FDA 510(k) clearance?

QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET received FDA 510(k) clearance on 1996-08-15, under 510(k) number K961912.

Who is the listed applicant for QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET?

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

What is the FDA product code for QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET?

The FDA product code for QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET is JJY.

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Other records listing Consolidated Technologies, 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.