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FDA 510(k)

ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID

K-Number: K883062 · 1988-08-04

ApplicantAlpha-Tec Systems, Inc.
Decision Date1988-08-04
Product CodeLDW
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID 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 1988-08-04 under 510(k) number K883062. The device is classified under product code LDW. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID?

ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K883062.

When did ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID receive FDA 510(k) clearance?

ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID received FDA 510(k) clearance on 1988-08-04, under 510(k) number K883062.

Who is the listed applicant for ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID?

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 SCHAUDINN'S FIXATIVE W/ACETIC ACID?

The FDA product code for ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID is LDW.

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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: LDW)

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.

K842923PICRIC ACID 1% W/VE K Ind., Inc.K842922PICRIC ACID SATURATED SOLUTIONE K Ind., Inc.K831058SAF FIXATIVEAmerican 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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