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FDA 510(k)

V-TREND KIT STAPH LATEX TEST

K-Number: K855220 · 1986-03-03

ApplicantTexas Immunology, Inc.
Decision Date1986-03-03
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

V-TREND KIT STAPH LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1986-03-03 under 510(k) number K855220. The device is classified under product code JWX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-TREND KIT STAPH LATEX TEST?

V-TREND KIT STAPH LATEX TEST is a medical device that received FDA 510(k) clearance on 1986-03-03. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K855220.

When did V-TREND KIT STAPH LATEX TEST receive FDA 510(k) clearance?

V-TREND KIT STAPH LATEX TEST received FDA 510(k) clearance on 1986-03-03, under 510(k) number K855220.

Who is the listed applicant for V-TREND KIT STAPH LATEX TEST?

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

What is the FDA product code for V-TREND KIT STAPH LATEX TEST?

The FDA product code for V-TREND KIT STAPH LATEX TEST is JWX.

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Other records listing Texas Immunology, 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.

K991465DRUG STOPK980153DRUG CHECKK973208FIRST SIGNK972094TARGET CARDIAC TROPONIN I TESTK963680TARGET MYOGLOBIN TESTK912246TARGET MICROALBUMINURIA TEST

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Related Devices (Code: JWX)

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.

K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTBinax, Inc.K972030STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUSOxoid , Ltd.K964315REMEL STAPH LATEX KITRemel, L.P.K945538STAPHAUREX PLUS(TM)Murex Diagnostics LimitdK926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.K923212SLIDEX STAPH-KITBiomerieux Vitek, 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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