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FDA 510(k)

DELFIA (TM) HFSH KIT

K-Number: K862043 · 1986-06-24

ApplicantLkb Instruments, Inc.
Decision Date1986-06-24
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA (TM) HFSH 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 1986-06-24 under 510(k) number K862043. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELFIA (TM) HFSH KIT?

DELFIA (TM) HFSH KIT is a medical device that received FDA 510(k) clearance on 1986-06-24. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K862043.

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

DELFIA (TM) HFSH KIT received FDA 510(k) clearance on 1986-06-24, under 510(k) number K862043.

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

The FDA product code for DELFIA (TM) HFSH KIT is CGJ.

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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: CGJ)

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.

K052662ONE STEP FSH MENOPAUSAL TESTInd Diagnostic, Inc.K043599MOMENTS MENOPAUSE CHECK, MODEL 9113Phamatech, Inc.K041165FSH MENOPAUSE PREDICTOR TESTACON Laboratories, Inc.K040575PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112Phamatech, Inc.K030058EARLYDETECT MENOPAUSE TEST FOR FSHEarly Detect, Inc.K002450GENUA MENOPAUSE MONITOR TEST KITGenua 1944, 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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