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FDA 510(k)

DIASCREEN REAGENT STRIPS

K-Number: K971976 · 1997-06-17

ApplicantDia-Screen Corp.
Decision Date1997-06-17
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 Dia-Screen Corp.. It received FDA 510(k) clearance on 1997-06-17 under 510(k) number K971976. 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 1997-06-17. The listed applicant is Dia-Screen Corp.. The 510(k) number is K971976.

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

DIASCREEN REAGENT STRIPS received FDA 510(k) clearance on 1997-06-17, under 510(k) number K971976.

Who is the listed applicant for DIASCREEN REAGENT STRIPS?

The FDA 510(k) record lists Dia-Screen Corp. 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.

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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.K981555DIASCREEN REAGENT STRIPSChronimed, Inc.K873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)Miles Laboratories, Inc.K843727LEUKOSTIX REAGENT STRIPS FOR URINALYSISMiles Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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