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FDA 510(k)

INNOVACON SPECTRUM II TEST CARD

K-Number: K061718 · 2006-11-13

ApplicantInnovacon, Inc.
Decision Date2006-11-13
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOVACON SPECTRUM II TEST CARD is the device name listed in this FDA 510(k) record. The listed applicant is Innovacon, Inc.. It received FDA 510(k) clearance on 2006-11-13 under 510(k) number K061718. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVACON SPECTRUM II TEST CARD?

INNOVACON SPECTRUM II TEST CARD is a medical device that received FDA 510(k) clearance on 2006-11-13. The listed applicant is Innovacon, Inc.. The 510(k) number is K061718.

When did INNOVACON SPECTRUM II TEST CARD receive FDA 510(k) clearance?

INNOVACON SPECTRUM II TEST CARD received FDA 510(k) clearance on 2006-11-13, under 510(k) number K061718.

Who is the listed applicant for INNOVACON SPECTRUM II TEST CARD?

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

What is the FDA product code for INNOVACON SPECTRUM II TEST CARD?

The FDA product code for INNOVACON SPECTRUM II TEST CARD is DKZ.

Related Clinical Trials

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Other records listing Innovacon, Inc. 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.

K063673INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICEK062361INNOVACON HCG UKTRA TEST DEVICE

Related Devices (Code: DKZ)

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.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.

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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