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FDA 510(k)

SERALYZER THEOPHYLLINE REAGENT STRIPS

K-Number: K832825 · 1984-03-19

ApplicantMiles Laboratories, Inc.
Decision Date1984-03-19
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SERALYZER THEOPHYLLINE REAGENT STRIPS 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 1984-03-19 under 510(k) number K832825. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERALYZER THEOPHYLLINE REAGENT STRIPS?

SERALYZER THEOPHYLLINE REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K832825.

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

SERALYZER THEOPHYLLINE REAGENT STRIPS received FDA 510(k) clearance on 1984-03-19, under 510(k) number K832825.

Who is the listed applicant for SERALYZER THEOPHYLLINE REAGENT STRIPS?

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 SERALYZER THEOPHYLLINE REAGENT STRIPS?

The FDA product code for SERALYZER THEOPHYLLINE REAGENT STRIPS is KLS.

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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: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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