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FDA 510(k)

BIO-RAD %CDT TIA

K-Number: K001651 · 2000-11-22

ApplicantAxis-Shield Biochemicals, Asa
Decision Date2000-11-22
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-RAD %CDT TIA is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Biochemicals, Asa. It received FDA 510(k) clearance on 2000-11-22 under 510(k) number K001651. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-RAD %CDT TIA?

BIO-RAD %CDT TIA is a medical device that received FDA 510(k) clearance on 2000-11-22. The listed applicant is Axis-Shield Biochemicals, Asa. The 510(k) number is K001651.

When did BIO-RAD %CDT TIA receive FDA 510(k) clearance?

BIO-RAD %CDT TIA received FDA 510(k) clearance on 2000-11-22, under 510(k) number K001651.

Who is the listed applicant for BIO-RAD %CDT TIA?

The FDA 510(k) record lists Axis-Shield Biochemicals, Asa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-RAD %CDT TIA?

The FDA product code for BIO-RAD %CDT TIA is JJX.

Other records listing Axis-Shield Biochemicals, Asa as applicant

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.

K030655HOLOTC RIA

Related Devices (Code: JJX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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