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FDA 510(k)

LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE

K-Number: K800899 · 1980-05-23

ApplicantMiles Laboratories, Inc.
Decision Date1980-05-23
Product CodeKZJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE 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 1980-05-23 under 510(k) number K800899. The device is classified under product code KZJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE?

LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE is a medical device that received FDA 510(k) clearance on 1980-05-23. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K800899.

When did LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE receive FDA 510(k) clearance?

LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE received FDA 510(k) clearance on 1980-05-23, under 510(k) number K800899.

Who is the listed applicant for LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE?

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 LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE?

The FDA product code for LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE is KZJ.

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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: KZJ)

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.

K881502BREWER GEL FOR CAMPYLOBACTERFairleigh Dickinson Laboratories, Inc.K875362BREWER GEL FOR ANAEROBESFairleigh Dickinson Laboratories, Inc.K872782BBL(R) GASPAK CO2 POUCH(TM)Bd Becton Dickinson Vacutainer Systems PreanalyticK871709ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)Difco Laboratories, Inc.K871238ANABAGScott Laboratories, Inc.K862123BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICEMarion Laboratories, 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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