FDA 510(k)

DELFIA TM HLH KIT

K-Number: K855173 · 1986-02-28

Decision Date1986-02-28

Product CodeCEP

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DELFIA TM HLH KIT 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 1986-02-28 under 510(k) number K855173. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELFIA TM HLH KIT?

DELFIA TM HLH KIT is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K855173.

When did DELFIA TM HLH KIT receive FDA 510(k) clearance?

DELFIA TM HLH KIT received FDA 510(k) clearance on 1986-02-28, under 510(k) number K855173.

Who is the listed applicant for DELFIA TM HLH KIT?

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 DELFIA TM HLH KIT?

The FDA product code for DELFIA TM HLH KIT is CEP.

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Other records listing Lkb Instruments, Inc. as applicant

K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTER K872955DELFIA(TM) FERRITIN KIT K871303DELFIA(TM) THYROXINE (T4) KIT K871599DELFIA(TM) HIGE KIT K871644DELFIA (TM) HTSH KIT K864452DELFIA(TM) TRIIODOTHYRONINE (T3) KIT

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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.