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FDA 510(k)

TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE

K-Number: K852611 · 1985-09-03

ApplicantMiles Laboratories, Inc.
Decision Date1985-09-03
Product CodeCDM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE 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 1985-09-03 under 510(k) number K852611. The device is classified under product code CDM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE?

TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE is a medical device that received FDA 510(k) clearance on 1985-09-03. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K852611.

When did TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE receive FDA 510(k) clearance?

TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE received FDA 510(k) clearance on 1985-09-03, under 510(k) number K852611.

Who is the listed applicant for TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE?

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 TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE?

The FDA product code for TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE is CDM.

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Related Devices (Code: CDM)

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.

K052719URITEST 10 URINALYSIS REAGENT STRIPSArj Medical, Inc.K061559ACON URINALYSIS REAGENT STRIPSAcon Laboratories Co.K880584URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8CMach Diag. C/O Wichita State UniversityK873366WAKO(TM) PRETEST 5AWako Chemicals USA, Inc.K830340FITKIT I CHECKUP KITBoditestorK821799FITKIT I CHECKUP KITPatton, Boggs & Blow

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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