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FDA 510(k)

ATS CRYPTOSPORIDIUM STAIN SET

K-Number: K880989 · 1988-05-13

ApplicantAlpha-Tec Systems, Inc.
Decision Date1988-05-13
Product CodeJTS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ATS CRYPTOSPORIDIUM STAIN SET 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 1988-05-13 under 510(k) number K880989. The device is classified under product code JTS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS CRYPTOSPORIDIUM STAIN SET?

ATS CRYPTOSPORIDIUM STAIN SET is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K880989.

When did ATS CRYPTOSPORIDIUM STAIN SET receive FDA 510(k) clearance?

ATS CRYPTOSPORIDIUM STAIN SET received FDA 510(k) clearance on 1988-05-13, under 510(k) number K880989.

Who is the listed applicant for ATS CRYPTOSPORIDIUM STAIN SET?

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 CRYPTOSPORIDIUM STAIN SET?

The FDA product code for ATS CRYPTOSPORIDIUM STAIN SET is JTS.

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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: JTS)

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.

K960090CALCOFLUOR WHITE STAIN KITRemel Co.K960095BACTIDROP CALCOFLUOR WHITERemel Co.K920970BACTIDROP KOH (10%)Remel Co.K920976BACTIDROP INDIA INKRemel Co.K920975BACTIDROP CALCOFLUOR WHITERemel Co.K893530IRISTAIN FORMULA 2, PARTS 1 AND 2Intl. Remote Imaging Systems

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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