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FDA 510(k)

ALT-QUANTICHROM

K-Number: K812926 · 1981-11-06

Decision Date1981-11-06
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALT-QUANTICHROM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812926. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALT-QUANTICHROM?

ALT-QUANTICHROM is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Abbott Laboratories. The 510(k) number is K812926.

When did ALT-QUANTICHROM receive FDA 510(k) clearance?

ALT-QUANTICHROM received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812926.

Who is the listed applicant for ALT-QUANTICHROM?

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

What is the FDA product code for ALT-QUANTICHROM?

The FDA product code for ALT-QUANTICHROM is CKA.

Related Clinical Trials

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.

Other records listing Abbott Laboratories 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.

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Related Devices (Code: CKA)

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.

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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