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FDA 510(k)

DELFIA (TM) HCG KIT

K-Number: K862044 · 1986-07-11

ApplicantLkb Instruments, Inc.
Decision Date1986-07-11
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA (TM) HCG 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 1986-07-11 under 510(k) number K862044. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELFIA (TM) HCG KIT?

DELFIA (TM) HCG KIT is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K862044.

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

DELFIA (TM) HCG KIT received FDA 510(k) clearance on 1986-07-11, under 510(k) number K862044.

Who is the listed applicant for DELFIA (TM) HCG 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) HCG KIT?

The FDA product code for DELFIA (TM) HCG KIT is JHJ.

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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.

K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTERK872955DELFIA(TM) FERRITIN KITK871303DELFIA(TM) THYROXINE (T4) KITK871599DELFIA(TM) HIGE KITK871644DELFIA (TM) HTSH KITK864452DELFIA(TM) TRIIODOTHYRONINE (T3) KIT

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Related Devices (Code: JHJ)

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.

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, 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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