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FDA 510(k)

AUTOCHECK6+

K-Number: K051928 · 2005-10-12

ApplicantRadiometer Medical Aps
Decision Date2005-10-12
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOCHECK6+ is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2005-10-12 under 510(k) number K051928. 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 AUTOCHECK6+?

AUTOCHECK6+ is a medical device that received FDA 510(k) clearance on 2005-10-12. The listed applicant is Radiometer Medical Aps. The 510(k) number is K051928.

When did AUTOCHECK6+ receive FDA 510(k) clearance?

AUTOCHECK6+ received FDA 510(k) clearance on 2005-10-12, under 510(k) number K051928.

Who is the listed applicant for AUTOCHECK6+?

The FDA 510(k) record lists Radiometer Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOCHECK6+?

The FDA product code for AUTOCHECK6+ is JJY.

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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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