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FDA 510(k)

B-STREP-TECT-II

K-Number: K840160 · 1984-03-02

ApplicantUti-Tect, Inc.
Decision Date1984-03-02
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

B-STREP-TECT-II 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 1984-03-02 under 510(k) number K840160. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-STREP-TECT-II?

B-STREP-TECT-II is a medical device that received FDA 510(k) clearance on 1984-03-02. The listed applicant is Uti-Tect, Inc.. The 510(k) number is K840160.

When did B-STREP-TECT-II receive FDA 510(k) clearance?

B-STREP-TECT-II received FDA 510(k) clearance on 1984-03-02, under 510(k) number K840160.

Who is the listed applicant for B-STREP-TECT-II?

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 B-STREP-TECT-II?

The FDA product code for B-STREP-TECT-II is JSI.

Related Clinical Trials

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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.

K840159GC-TECTK812581SENSI-TECT

Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK974428DIPSTREAKNovamed , Ltd.K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K890199DENTOCULT SM-STRIP MUTANSOrion Corp.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881575SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, 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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