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FDA 510(k)

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

K-Number: K023335 · 2003-06-18

ApplicantQc Sciences, LLC
Decision Date2003-06-18
Product CodeNJW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) is the device name listed in this FDA 510(k) record. The listed applicant is Qc Sciences, LLC. It received FDA 510(k) clearance on 2003-06-18 under 510(k) number K023335. The device is classified under product code NJW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)?

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) is a medical device that received FDA 510(k) clearance on 2003-06-18. The listed applicant is Qc Sciences, LLC. The 510(k) number is K023335.

When did QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) receive FDA 510(k) clearance?

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) received FDA 510(k) clearance on 2003-06-18, under 510(k) number K023335.

Who is the listed applicant for QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)?

The FDA 510(k) record lists Qc Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)?

The FDA product code for QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) is NJW.

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Related Devices (Code: NJW)

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.

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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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