FDA 510(k)

QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3

K-Number: K972080 · 1997-06-18

ApplicantConsolidated Technologies, Inc.

Decision Date1997-06-18

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 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 1997-06-18 under 510(k) number K972080. 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 DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3?

QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 is a medical device that received FDA 510(k) clearance on 1997-06-18. The listed applicant is Consolidated Technologies, Inc.. The 510(k) number is K972080.

When did QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 receive FDA 510(k) clearance?

QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 received FDA 510(k) clearance on 1997-06-18, under 510(k) number K972080.

Who is the listed applicant for QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3?

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 DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3?

The FDA product code for QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 is JJY.

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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.