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FDA 510(k)

GRAM NEGATIVE BACTERIAL IDENTIF- PANELS

K-Number: K823738 · 1983-01-07

ApplicantMicro-Media Systems, Inc.
Decision Date1983-01-07
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GRAM NEGATIVE BACTERIAL IDENTIF- PANELS is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Media Systems, Inc.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823738. 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 GRAM NEGATIVE BACTERIAL IDENTIF- PANELS?

GRAM NEGATIVE BACTERIAL IDENTIF- PANELS is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Micro-Media Systems, Inc.. The 510(k) number is K823738.

When did GRAM NEGATIVE BACTERIAL IDENTIF- PANELS receive FDA 510(k) clearance?

GRAM NEGATIVE BACTERIAL IDENTIF- PANELS received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823738.

Who is the listed applicant for GRAM NEGATIVE BACTERIAL IDENTIF- PANELS?

The FDA 510(k) record lists Micro-Media Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRAM NEGATIVE BACTERIAL IDENTIF- PANELS?

The FDA product code for GRAM NEGATIVE BACTERIAL IDENTIF- PANELS is JTO.

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Other records listing Micro-Media 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.

K953422FOX FASTIDIOUS TEST PANELSK945997MODIFIED FOX EXTRA GRAM POSITIVEK801547TEST PANEL FOR PRESUMP. ID/BACT. ORGK791991STREP-SPECK770745PANEL, GNF, MICRO-IDK770746PANEL, IDENTIFICATION, STREP, MICRO-ID

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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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