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FDA 510(k)

ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP

K-Number: K061014 · 2006-05-10

ApplicantHelena Laboratories
Decision Date2006-05-10
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2006-05-10 under 510(k) number K061014. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP?

ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP is a medical device that received FDA 510(k) clearance on 2006-05-10. The listed applicant is Helena Laboratories. The 510(k) number is K061014.

When did ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP receive FDA 510(k) clearance?

ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP received FDA 510(k) clearance on 2006-05-10, under 510(k) number K061014.

Who is the listed applicant for ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP?

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

What is the FDA product code for ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP?

The FDA product code for ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP is JPA.

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Related Devices (Code: JPA)

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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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