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FDA 510(k)

CLEARVIEW IM

K-Number: K981946 · 1998-12-10

ApplicantUnipath , Ltd.
Decision Date1998-12-10
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CLEARVIEW IM is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1998-12-10 under 510(k) number K981946. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARVIEW IM?

CLEARVIEW IM is a medical device that received FDA 510(k) clearance on 1998-12-10. The listed applicant is Unipath , Ltd.. The 510(k) number is K981946.

When did CLEARVIEW IM receive FDA 510(k) clearance?

CLEARVIEW IM received FDA 510(k) clearance on 1998-12-10, under 510(k) number K981946.

Who is the listed applicant for CLEARVIEW IM?

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

What is the FDA product code for CLEARVIEW IM?

The FDA product code for CLEARVIEW IM is KTN.

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Other records listing Unipath , 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.

K061769E.P.T. CERTAINTY 1-STEP PREGNANCY TESTK060128CLEARBLUE EASY DIGITAL PREGNANCY TESTK051638INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBCK050930E.P.T. CERTAINTY PREGNANCY TESTK042280FACT PLUS ONE-STEP PREGNANCY TEST KITK041404CLEARBLUE EASY EASY READ PREGNANCY TEST

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Related Devices (Code: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K972457MONOCOL/LEX-IM TESTImmunostics 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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