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FDA 510(k)

CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

K-Number: K873304 · 1987-09-11

ApplicantMiles Laboratories, Inc.
Decision Date1987-09-11
Product CodeLJX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1987-09-11 under 510(k) number K873304. 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 CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)?

CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) is a medical device that received FDA 510(k) clearance on 1987-09-11. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K873304.

When did CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) receive FDA 510(k) clearance?

CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) received FDA 510(k) clearance on 1987-09-11, under 510(k) number K873304.

Who is the listed applicant for CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)?

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

What is the FDA product code for CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)?

The FDA product code for CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) is LJX.

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Other records listing Miles Laboratories, 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.

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK872634CUTTER PUREFLO PLUS IV FILTER

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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.K971976DIASCREEN REAGENT STRIPSDia-Screen Corp.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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