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FDA 510(k)

VANCOMYCIN 5MCG DIFFERENTIAL DISK

K-Number: K844382 · 1985-01-04

ApplicantAnaerobe Systems
Decision Date1985-01-04
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VANCOMYCIN 5MCG DIFFERENTIAL DISK is the device name listed in this FDA 510(k) record. The listed applicant is Anaerobe Systems. It received FDA 510(k) clearance on 1985-01-04 under 510(k) number K844382. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANCOMYCIN 5MCG DIFFERENTIAL DISK?

VANCOMYCIN 5MCG DIFFERENTIAL DISK is a medical device that received FDA 510(k) clearance on 1985-01-04. The listed applicant is Anaerobe Systems. The 510(k) number is K844382.

When did VANCOMYCIN 5MCG DIFFERENTIAL DISK receive FDA 510(k) clearance?

VANCOMYCIN 5MCG DIFFERENTIAL DISK received FDA 510(k) clearance on 1985-01-04, under 510(k) number K844382.

Who is the listed applicant for VANCOMYCIN 5MCG DIFFERENTIAL DISK?

The FDA 510(k) record lists Anaerobe Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VANCOMYCIN 5MCG DIFFERENTIAL DISK?

The FDA product code for VANCOMYCIN 5MCG DIFFERENTIAL DISK is JTO.

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Other records listing Anaerobe Systems 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.

K844380BILE DIFFERENTIAL DISKK844381COLISTIN 10 MCG. DIFFERENTIAL DISKK844383KANAMYCIN 1000 MCG DIFFERENTIAL DISKK841303CAMPYLOBACTER THIOGLYCOLLATE MEDK841142LEVINE EOSIN METHYLENE BLUE AGARK841218CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR

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Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, 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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