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FDA 510(k)

AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5

K-Number: K100718 · 2010-09-03

ApplicantAalto Scientific, Ltd.
Decision Date2010-09-03
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-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 2010-09-03 under 510(k) number K100718. 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 AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5?

AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 is a medical device that received FDA 510(k) clearance on 2010-09-03. The listed applicant is Aalto Scientific, Ltd.. The 510(k) number is K100718.

When did AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 receive FDA 510(k) clearance?

AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 received FDA 510(k) clearance on 2010-09-03, under 510(k) number K100718.

Who is the listed applicant for AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-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 AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5?

The FDA product code for AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-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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