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FDA 510(k)

ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION

K-Number: K880990 · 1988-03-24

ApplicantAlpha-Tec Systems, Inc.
Decision Date1988-03-24
Product CodeJSY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION 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 1988-03-24 under 510(k) number K880990. The device is classified under product code JSY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION?

ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION is a medical device that received FDA 510(k) clearance on 1988-03-24. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K880990.

When did ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION receive FDA 510(k) clearance?

ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION received FDA 510(k) clearance on 1988-03-24, under 510(k) number K880990.

Who is the listed applicant for ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION?

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 0.2% BOVINE ALBUMIN FRACTION V SOLUTION?

The FDA product code for ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION is JSY.

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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 #034-45K890022ATS MAYER'S ALBUMINK883048ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION

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Related Devices (Code: JSY)

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.

K943051MYCOAKT M. TUBERCULOSIS CUULTURE ID KITDynagen, Inc.K943050MYCOAKT M KANSASII CULTURE ID KITDynagen, Inc.K943049MYCOAKT M. AVIUM CULTURE ID KITDynagen, Inc.K830211API TB-IDENT*Analytical Products, Inc.

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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