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FDA 510(k)

Audit MicroControls Linearity FD Tumor Markers II

K-Number: K163629 · 2017-03-10

ApplicantAalto Scientific, Ltd.
Decision Date2017-03-10
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Audit MicroControls Linearity FD Tumor Markers II is the device name listed in this FDA 510(k) record. The listed applicant is Aalto Scientific, Ltd.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K163629. 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 Audit MicroControls Linearity FD Tumor Markers II?

Audit MicroControls Linearity FD Tumor Markers II is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is Aalto Scientific, Ltd.. The 510(k) number is K163629.

When did Audit MicroControls Linearity FD Tumor Markers II receive FDA 510(k) clearance?

Audit MicroControls Linearity FD Tumor Markers II received FDA 510(k) clearance on 2017-03-10, under 510(k) number K163629.

Who is the listed applicant for Audit MicroControls Linearity FD Tumor Markers II?

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

What is the FDA product code for Audit MicroControls Linearity FD Tumor Markers II?

The FDA product code for Audit MicroControls Linearity FD Tumor Markers II is JJY.

Other records listing Aalto Scientific, Ltd. 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.

K161874Audit MicroControls Linearity DROP LQ Blood Glucose

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 ManufacturingK163015Liquichek 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.

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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