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FDA 510(k)

REAGENT STRIPS FOR URINALYSIS

K-Number: K811342 · 1981-09-01

ApplicantMiles Laboratories, Inc.
Decision Date1981-09-01
Product CodeJRE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT STRIPS FOR URINALYSIS 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 1981-09-01 under 510(k) number K811342. The device is classified under product code JRE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT STRIPS FOR URINALYSIS?

REAGENT STRIPS FOR URINALYSIS is a medical device that received FDA 510(k) clearance on 1981-09-01. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K811342.

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

REAGENT STRIPS FOR URINALYSIS received FDA 510(k) clearance on 1981-09-01, under 510(k) number K811342.

Who is the listed applicant for REAGENT STRIPS FOR URINALYSIS?

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 REAGENT STRIPS FOR URINALYSIS?

The FDA product code for REAGENT STRIPS FOR URINALYSIS is JRE.

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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 ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

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Related Devices (Code: JRE)

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.

K954977URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)Teco DiagnosticsK941906MODEL 2730 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941903MODEL 2740 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941901MODEL 2721 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941904MODEL A300CL CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941905MODEL 3461 CLINICAL REFRACTOMETERVee Gee Scientific, 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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