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FDA 510(k)

ATS GRAM STAIN CONTROL SLIDE

K-Number: K823704 · 1983-01-07

ApplicantAlpha-Tec Systems, Inc.
Decision Date1983-01-07
Product CodeLJG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ATS GRAM STAIN CONTROL SLIDE 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 1983-01-07 under 510(k) number K823704. The device is classified under product code LJG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS GRAM STAIN CONTROL SLIDE?

ATS GRAM STAIN CONTROL SLIDE is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K823704.

When did ATS GRAM STAIN CONTROL SLIDE receive FDA 510(k) clearance?

ATS GRAM STAIN CONTROL SLIDE received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823704.

Who is the listed applicant for ATS GRAM STAIN CONTROL SLIDE?

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 GRAM STAIN CONTROL SLIDE?

The FDA product code for ATS GRAM STAIN CONTROL SLIDE is LJG.

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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

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Related Devices (Code: LJG)

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.

K943228MICROSPORIDIUM CONTROL SETMeridian Diagnostics, Inc.K924893MICROSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.K890670CRYPTOSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.K890718GRAM STAIN CONTROL SLIDEScientific Device Laboratory, Inc.K890616BION DIRECT IDENTIFICATION CONTROL SLIDEBion Ent., Ltd.K883569HISTO-CHECK GRAM NEGATIVE SLIDESVal Tech Diagnostics, 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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