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FDA 510(k)

TILL-U=TEST

K-Number: K780109 · 1978-01-31

ApplicantClinifax Industries, Ltd.
Decision Date1978-01-31
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TILL-U=TEST is the device name listed in this FDA 510(k) record. The listed applicant is Clinifax Industries, Ltd.. It received FDA 510(k) clearance on 1978-01-31 under 510(k) number K780109. 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 TILL-U=TEST?

TILL-U=TEST is a medical device that received FDA 510(k) clearance on 1978-01-31. The listed applicant is Clinifax Industries, Ltd.. The 510(k) number is K780109.

When did TILL-U=TEST receive FDA 510(k) clearance?

TILL-U=TEST received FDA 510(k) clearance on 1978-01-31, under 510(k) number K780109.

Who is the listed applicant for TILL-U=TEST?

The FDA 510(k) record lists Clinifax Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TILL-U=TEST?

The FDA product code for TILL-U=TEST is JXA.

Other records listing Clinifax Industries, Ltd. 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.

K781421BIOSCAN E12

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.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & 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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