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FDA 510(k)

URINE DUO

K-Number: K851225 · 1985-08-13

ApplicantCulture Kits, Inc.
Decision Date1985-08-13
Product CodeJTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

URINE DUO is the device name listed in this FDA 510(k) record. The listed applicant is Culture Kits, Inc.. It received FDA 510(k) clearance on 1985-08-13 under 510(k) number K851225. 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 URINE DUO?

URINE DUO is a medical device that received FDA 510(k) clearance on 1985-08-13. The listed applicant is Culture Kits, Inc.. The 510(k) number is K851225.

When did URINE DUO receive FDA 510(k) clearance?

URINE DUO received FDA 510(k) clearance on 1985-08-13, under 510(k) number K851225.

Who is the listed applicant for URINE DUO?

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

What is the FDA product code for URINE DUO?

The FDA product code for URINE DUO is JTZ.

Related Clinical Trials

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.

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Other records listing Culture Kits, 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.

K911846URI-THREE(TM), MODIFICATIONK854672CANDI-KIT TMK853488STAPH KITK852582GONI-KITK852480DERM-KITK851518MUELLER HINTON SENSITIVITY PLATE

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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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