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FDA 510(k)

LKB 4460 FLUORIMETER

K-Number: K811019 · 1981-04-29

ApplicantLkb Instruments, Inc.
Decision Date1981-04-29
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LKB 4460 FLUORIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K811019. The device is classified under product code KHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LKB 4460 FLUORIMETER?

LKB 4460 FLUORIMETER is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K811019.

When did LKB 4460 FLUORIMETER receive FDA 510(k) clearance?

LKB 4460 FLUORIMETER received FDA 510(k) clearance on 1981-04-29, under 510(k) number K811019.

Who is the listed applicant for LKB 4460 FLUORIMETER?

The FDA 510(k) record lists Lkb Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LKB 4460 FLUORIMETER?

The FDA product code for LKB 4460 FLUORIMETER is KHO.

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Other records listing Lkb Instruments, 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.

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Related Devices (Code: KHO)

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.

K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Radiometer Medical ApsK973547TRIAGE STATMETERBiosite IncorporatedK971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.K962919VITROS IMMUNODIAGNOSTIC SYSTEMJohnson & Johnson Clinical Diagnostics, Inc.K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)Biocircuits Corp.K950415FLUOROSCAN NEONATALIsolab, 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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