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FDA 510(k)

AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET

K-Number: K853081 · 1985-08-13

ApplicantAdvanced Medical Technology, Inc.
Decision Date1985-08-13
Product CodeKJK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Technology, Inc.. It received FDA 510(k) clearance on 1985-08-13 under 510(k) number K853081. The device is classified under product code KJK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET?

AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET is a medical device that received FDA 510(k) clearance on 1985-08-13. The listed applicant is Advanced Medical Technology, Inc.. The 510(k) number is K853081.

When did AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET receive FDA 510(k) clearance?

AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET received FDA 510(k) clearance on 1985-08-13, under 510(k) number K853081.

Who is the listed applicant for AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET?

The FDA 510(k) record lists Advanced Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET?

The FDA product code for AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET is KJK.

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Other records listing Advanced Medical Technology, 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.

K083626DISTRACTABLE WAVE CAGEK874571PATIENTWATCH (TM)K862777MODEL A-8000 ULTRASONIC HANDPIECE CORDK854225ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYSK852997RAPI - STAPHK853187ACRIDINE ORANGE FLUORESCENT STAIN

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Related Devices (Code: KJK)

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.

K812274AURAMINE O MYCROBACTERIAL STAIN SETCarr-Scarborough Microbiologicals, 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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