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FDA 510(k)

AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5

K-Number: K082717 · 2008-10-30

ApplicantAalto Scientific, Ltd.
Decision Date2008-10-30
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 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 2008-10-30 under 510(k) number K082717. 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 MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5?

AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 is a medical device that received FDA 510(k) clearance on 2008-10-30. The listed applicant is Aalto Scientific, Ltd.. The 510(k) number is K082717.

When did AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 receive FDA 510(k) clearance?

AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 received FDA 510(k) clearance on 2008-10-30, under 510(k) number K082717.

Who is the listed applicant for AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5?

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 MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5?

The FDA product code for AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 is JJY.

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Other records listing Aalto Scientific, Ltd. as applicant

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K163629Audit MicroControls Linearity FD Tumor Markers IIK161874Audit MicroControls Linearity DROP LQ Blood GlucoseK130762AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SETK130764AUDIT MICROCV VITAMIN D LINEARITY SETK130157AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SETK112742AUDIT MICROLQ SPINAL FLUID CONTROL

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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