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FDA 510(k)

ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION

K-Number: K883048 · 1988-08-17

ApplicantAlpha-Tec Systems, Inc.
Decision Date1988-08-17
Product CodeLDZ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

ATS PARA-SET MODIFIED PVA FIXATIVE 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 1988-08-17 under 510(k) number K883048. The device is classified under product code LDZ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION?

ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION is a medical device that received FDA 510(k) clearance on 1988-08-17. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K883048.

When did ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION receive FDA 510(k) clearance?

ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION received FDA 510(k) clearance on 1988-08-17, under 510(k) number K883048.

Who is the listed applicant for ATS PARA-SET MODIFIED PVA FIXATIVE 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 PARA-SET MODIFIED PVA FIXATIVE SOLUTION?

The FDA product code for ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION is LDZ.

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.

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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 ALBUMINK883049ATS PARA-SET IODINE ALCOHOL SOLUTION

View all 18 devices →

Related Devices (Code: LDZ)

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.

K881922CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVESurgipath Medical Industries, Inc.K881698ATS PVA FIXATIVE SOLUTIONAlpha-Tec Systems, Inc.K862725SACCOMANNO SPECIMAN SOLUTIONMill-Rose LaboratoryK843428BIOFIXAccra Laboratories, Inc.K842913WRIGHT STAIN FIXATIVEE K Ind., Inc.K831061PVA FIXATIVE/FORMALINAmerican Micro Scan

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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