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FDA 510(k)

SERALYZER III BLOOD CHEMISTRY ANALYZER

K-Number: K872120 · 1987-10-28

ApplicantMiles Laboratories, Inc.
Decision Date1987-10-28
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERALYZER III BLOOD CHEMISTRY ANALYZER 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 1987-10-28 under 510(k) number K872120. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERALYZER III BLOOD CHEMISTRY ANALYZER?

SERALYZER III BLOOD CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1987-10-28. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K872120.

When did SERALYZER III BLOOD CHEMISTRY ANALYZER receive FDA 510(k) clearance?

SERALYZER III BLOOD CHEMISTRY ANALYZER received FDA 510(k) clearance on 1987-10-28, under 510(k) number K872120.

Who is the listed applicant for SERALYZER III BLOOD CHEMISTRY ANALYZER?

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 III BLOOD CHEMISTRY ANALYZER?

The FDA product code for SERALYZER III BLOOD CHEMISTRY ANALYZER is JJF.

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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 PRINTK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)K872634CUTTER PUREFLO PLUS IV FILTER

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Related Devices (Code: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, 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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