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FDA 510(k)

TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT

K-Number: K952246 · 1995-06-20

ApplicantTri-Tech, Inc.
Decision Date1995-06-20
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Tech, Inc.. It received FDA 510(k) clearance on 1995-06-20 under 510(k) number K952246. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT?

TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT is a medical device that received FDA 510(k) clearance on 1995-06-20. The listed applicant is Tri-Tech, Inc.. The 510(k) number is K952246.

When did TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT receive FDA 510(k) clearance?

TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT received FDA 510(k) clearance on 1995-06-20, under 510(k) number K952246.

Who is the listed applicant for TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT?

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

What is the FDA product code for TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT?

The FDA product code for TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT is JXA.

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Other records listing Tri-Tech, 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.

K971111TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPERK922343TRI-TECH INC. CUSTOM SEXUAL ASSAULT KITK922342TRI-TECH INC. CUSTOM BLOOD ALCOHOLK912140STAIRMASTER MODEL 6000 ERGOMETERK912056GRAVITRON UPPER BODY SYSTEM EXERCISERK9120574000 PT EXERCISE SYSTEM

View all 11 devices →

Related Devices (Code: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950246MULTIPLE (IZON URINE COLLECTION KIT)Izon Business Products, Inc.K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)Izon Business Products, 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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