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FDA 510(k)

SERALYZER BLOOD UREA NITROGEN(BUN)

K-Number: K801269 · 1980-07-08

ApplicantMiles Laboratories, Inc.
Decision Date1980-07-08
Product CodeJGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERALYZER BLOOD UREA NITROGEN(BUN) 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 1980-07-08 under 510(k) number K801269. The device is classified under product code JGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERALYZER BLOOD UREA NITROGEN(BUN)?

SERALYZER BLOOD UREA NITROGEN(BUN) is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K801269.

When did SERALYZER BLOOD UREA NITROGEN(BUN) receive FDA 510(k) clearance?

SERALYZER BLOOD UREA NITROGEN(BUN) received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801269.

Who is the listed applicant for SERALYZER BLOOD UREA NITROGEN(BUN)?

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 BLOOD UREA NITROGEN(BUN)?

The FDA product code for SERALYZER BLOOD UREA NITROGEN(BUN) is JGZ.

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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: JGZ)

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.

K904049ROCHE COBAS READY RENAL PROFILE REAGENT STRIPRoche Diagnostic Systems, Inc.K896236COBAS READY BUN REAGENTRoche Diagnostic Systems, Inc.K883327CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TESTHeraeus Kulzer, Inc.K863901IQ UREA NITROGENBd Becton Dickinson Vacutainer Systems PreanalyticK842772PHARMACIA B2-MICRO RIAPharmacia, Inc.K840213BLOOD UREA NITROGEN REAGENT SYSSclavo, 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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