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FDA 510(k)

AURAMINE O MYCROBACTERIAL STAIN SET

K-Number: K812274 · 1981-09-01

ApplicantCarr-Scarborough Microbiologicals, Inc.
Decision Date1981-09-01
Product CodeKJK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AURAMINE O MYCROBACTERIAL STAIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Carr-Scarborough Microbiologicals, Inc.. It received FDA 510(k) clearance on 1981-09-01 under 510(k) number K812274. 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 MYCROBACTERIAL STAIN SET?

AURAMINE O MYCROBACTERIAL STAIN SET is a medical device that received FDA 510(k) clearance on 1981-09-01. The listed applicant is Carr-Scarborough Microbiologicals, Inc.. The 510(k) number is K812274.

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

AURAMINE O MYCROBACTERIAL STAIN SET received FDA 510(k) clearance on 1981-09-01, under 510(k) number K812274.

Who is the listed applicant for AURAMINE O MYCROBACTERIAL STAIN SET?

The FDA 510(k) record lists Carr-Scarborough Microbiologicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Carr-Scarborough Microbiologicals, Inc. as applicant

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K944554BRAIN HEART INFUSION AGARK941985MUELLER HINTON AGAR W/OXACILLINK905472LAP DISCSK905666M. CAT. BUTYRATE DISCK891476C. ALBICANS SCREENK882630PRO DISCS

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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.

K853081AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SETAdvanced Medical Technology, 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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