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FDA 510(k)

ATS TB RAPID STAIN SET PRODUCT #034-45

K-Number: K890148 · 1989-01-24

ApplicantAlpha-Tec Systems, Inc.
Decision Date1989-01-24
Product CodeICL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ATS TB RAPID STAIN SET PRODUCT #034-45 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 1989-01-24 under 510(k) number K890148. The device is classified under product code ICL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS TB RAPID STAIN SET PRODUCT #034-45?

ATS TB RAPID STAIN SET PRODUCT #034-45 is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K890148.

When did ATS TB RAPID STAIN SET PRODUCT #034-45 receive FDA 510(k) clearance?

ATS TB RAPID STAIN SET PRODUCT #034-45 received FDA 510(k) clearance on 1989-01-24, under 510(k) number K890148.

Who is the listed applicant for ATS TB RAPID STAIN SET PRODUCT #034-45?

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 TB RAPID STAIN SET PRODUCT #034-45?

The FDA product code for ATS TB RAPID STAIN SET PRODUCT #034-45 is ICL.

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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 SOLUTIONK890022ATS MAYER'S ALBUMINK883048ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTIONK883049ATS PARA-SET IODINE ALCOHOL SOLUTION

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Related Devices (Code: ICL)

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.

K842933CARBOL-FUCHSIN, ZIEHL-NEEDSENE K Ind., Inc.K792483STAINS, COUNTERSTAINS & GEN. PURPOSELaboratory Products, Inc.K771390HISTOCHEMICAL AFB DEMONSTRATIONHarleco

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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