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FDA 510(k)

SERIM LEUKOCYTE ESTERASE TEST STRIPS

K-Number: K000578 · 2000-05-05

ApplicantSerim Research Corp.
Decision Date2000-05-05
Product CodeLJX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SERIM LEUKOCYTE ESTERASE TEST STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research Corp.. It received FDA 510(k) clearance on 2000-05-05 under 510(k) number K000578. 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 SERIM LEUKOCYTE ESTERASE TEST STRIPS?

SERIM LEUKOCYTE ESTERASE TEST STRIPS is a medical device that received FDA 510(k) clearance on 2000-05-05. The listed applicant is Serim Research Corp.. The 510(k) number is K000578.

When did SERIM LEUKOCYTE ESTERASE TEST STRIPS receive FDA 510(k) clearance?

SERIM LEUKOCYTE ESTERASE TEST STRIPS received FDA 510(k) clearance on 2000-05-05, under 510(k) number K000578.

Who is the listed applicant for SERIM LEUKOCYTE ESTERASE TEST STRIPS?

The FDA 510(k) record lists Serim Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERIM LEUKOCYTE ESTERASE TEST STRIPS?

The FDA product code for SERIM LEUKOCYTE ESTERASE TEST STRIPS is LJX.

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Other records listing Serim Research Corp. as applicant

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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.K981555DIASCREEN REAGENT STRIPSChronimed, Inc.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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