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FDA 510(k)

DIASCREEN REAGENT STRIPS

K-Number: K981555 · 1998-06-01

ApplicantChronimed, Inc.
Decision Date1998-06-01
Product CodeLJX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIASCREEN REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Chronimed, Inc.. It received FDA 510(k) clearance on 1998-06-01 under 510(k) number K981555. The device is classified under product code LJX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIASCREEN REAGENT STRIPS?

DIASCREEN REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1998-06-01. The listed applicant is Chronimed, Inc.. The 510(k) number is K981555.

When did DIASCREEN REAGENT STRIPS receive FDA 510(k) clearance?

DIASCREEN REAGENT STRIPS received FDA 510(k) clearance on 1998-06-01, under 510(k) number K981555.

Who is the listed applicant for DIASCREEN REAGENT STRIPS?

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

What is the FDA product code for DIASCREEN REAGENT STRIPS?

The FDA product code for DIASCREEN REAGENT STRIPS is LJX.

Related Clinical Trials

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.

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Other records listing Chronimed, 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.

K010039QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTIONK983432SUPREME II CONTROL SOLUTIONSK980573SENSOREX BLOOD GLUCOSE MONITORING SYSTEMK963544SUPREME II METER

Related Devices (Code: LJX)

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.

K231045Healgen URS Test StripsHealgen Scientific,, LLCK063295ACON UTI URINARY TRACT INFECTION TEST STRIPSACON Laboratories, Inc.K000578SERIM LEUKOCYTE ESTERASE TEST STRIPSSerim Research Corp.K971976DIASCREEN REAGENT STRIPSDia-Screen Corp.K873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)Miles Laboratories, Inc.K843727LEUKOSTIX REAGENT STRIPS FOR URINALYSISMiles Laboratories, 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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