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FDA 510(k)

CULTURE AND SENSITIVITY KIT

K-Number: K791413 · 1979-10-17

ApplicantBiomedia, Inc.
Decision Date1979-10-17
Product CodeJTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CULTURE AND SENSITIVITY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biomedia, Inc.. It received FDA 510(k) clearance on 1979-10-17 under 510(k) number K791413. The device is classified under product code JTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CULTURE AND SENSITIVITY KIT?

CULTURE AND SENSITIVITY KIT is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Biomedia, Inc.. The 510(k) number is K791413.

When did CULTURE AND SENSITIVITY KIT receive FDA 510(k) clearance?

CULTURE AND SENSITIVITY KIT received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791413.

Who is the listed applicant for CULTURE AND SENSITIVITY KIT?

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

What is the FDA product code for CULTURE AND SENSITIVITY KIT?

The FDA product code for CULTURE AND SENSITIVITY KIT is JTZ.

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Other records listing Biomedia, 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.

K821300#2010 CAMPHYLOBACTER AGARK821301#50002 QUAD DIAGNOSTIC SYSTEMK821302#50003 QUAD DIAGNOSTIC SYSTEMK821108BI PLATE-XLD/HEKTOEN #30012K811478EMB AGAR, LEVINEK811477MACCONKEY AGAR

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Related Devices (Code: JTZ)

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.

K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton BrothBecton Dickinson and CompanyK963036MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOODBecton Dickinson Microbiology SystemsK960420MUELLER HINTON AGAR WITH 5% SHEEP BLOODBecton Dickinson Microbiology SystemsK960313MUELLER HINTON AGAR WITH 2% NACIRemel, L.P.K945911CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARSBioclinical Systems, Inc.K941985MUELLER HINTON AGAR W/OXACILLINCarr-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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