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FDA 510(k)

AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY

K-Number: K111964 · 2012-03-02

ApplicantAalto Scientific, Ltd.
Decision Date2012-03-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY 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 2012-03-02 under 510(k) number K111964. 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 URINE/FLUIDS CHEMISTRY LINEARITY?

AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY is a medical device that received FDA 510(k) clearance on 2012-03-02. The listed applicant is Aalto Scientific, Ltd.. The 510(k) number is K111964.

When did AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY receive FDA 510(k) clearance?

AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY received FDA 510(k) clearance on 2012-03-02, under 510(k) number K111964.

Who is the listed applicant for AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY?

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 URINE/FLUIDS CHEMISTRY LINEARITY?

The FDA product code for AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY 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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