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FDA 510(k)

SERALYZER CREATININE REAGENT STRIPS

K-Number: K820075 · 1982-01-26

ApplicantMiles Laboratories, Inc.
Decision Date1982-01-26
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERALYZER CREATININE 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 1982-01-26 under 510(k) number K820075. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERALYZER CREATININE REAGENT STRIPS?

SERALYZER CREATININE REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1982-01-26. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K820075.

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

SERALYZER CREATININE REAGENT STRIPS received FDA 510(k) clearance on 1982-01-26, under 510(k) number K820075.

Who is the listed applicant for SERALYZER CREATININE 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 CREATININE REAGENT STRIPS?

The FDA product code for SERALYZER CREATININE REAGENT STRIPS is CGX.

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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: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, 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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