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FDA 510(k)

ATS MAYER'S ALBUMIN

K-Number: K890022 · 1989-01-10

ApplicantAlpha-Tec Systems, Inc.
Decision Date1989-01-10
Product CodeKEL
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

ATS MAYER'S ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Tec Systems, Inc.. It received FDA 510(k) clearance on 1989-01-10 under 510(k) number K890022. The device is classified under product code KEL. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS MAYER'S ALBUMIN?

ATS MAYER'S ALBUMIN is a medical device that received FDA 510(k) clearance on 1989-01-10. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K890022.

When did ATS MAYER'S ALBUMIN receive FDA 510(k) clearance?

ATS MAYER'S ALBUMIN received FDA 510(k) clearance on 1989-01-10, under 510(k) number K890022.

Who is the listed applicant for ATS MAYER'S ALBUMIN?

The FDA 510(k) record lists Alpha-Tec Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATS MAYER'S ALBUMIN?

The FDA product code for ATS MAYER'S ALBUMIN is KEL.

Related Clinical Trials

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Other records listing Alpha-Tec Systems, Inc. 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.

K053257PARA-PRO FC50K890861ATS DOBELL & O'CONNOR'S IODINEK890020ATS LUGOL'S IODINE SOLUTIONK890148ATS TB RAPID STAIN SET PRODUCT #034-45K883048ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTIONK883049ATS PARA-SET IODINE ALCOHOL SOLUTION

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Related Devices (Code: KEL)

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.

K881477HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTEDStat Path

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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