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FDA 510(k)

QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3

K-Number: K001249 · 2000-11-02

ApplicantConsolidated Technologies of Wisconsin
Decision Date2000-11-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Technologies of Wisconsin. It received FDA 510(k) clearance on 2000-11-02 under 510(k) number K001249. 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?

QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 is a medical device that received FDA 510(k) clearance on 2000-11-02. The listed applicant is Consolidated Technologies of Wisconsin. The 510(k) number is K001249.

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

QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 received FDA 510(k) clearance on 2000-11-02, under 510(k) number K001249.

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

The FDA 510(k) record lists Consolidated Technologies of Wisconsin 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?

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

Related Clinical Trials

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Other records listing Consolidated Technologies of Wisconsin as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000810QUALITROL LIPID CONTROL, LEVELS 1 AND 2

Related Devices (Code: JJY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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.

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