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FDA 510(k)

SENSI-TECT

K-Number: K812581 · 1981-09-23

ApplicantUti-Tect, Inc.
Decision Date1981-09-23
Product CodeJTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSI-TECT is the device name listed in this FDA 510(k) record. The listed applicant is Uti-Tect, Inc.. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812581. 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 SENSI-TECT?

SENSI-TECT is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Uti-Tect, Inc.. The 510(k) number is K812581.

When did SENSI-TECT receive FDA 510(k) clearance?

SENSI-TECT received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812581.

Who is the listed applicant for SENSI-TECT?

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

What is the FDA product code for SENSI-TECT?

The FDA product code for SENSI-TECT 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 Uti-Tect, 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.

K840160B-STREP-TECT-IIK840159GC-TECT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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