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FDA 510(k)

ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT

K-Number: K922376 · 1992-10-05

ApplicantIcn Biomedicals, Inc.
Decision Date1992-10-05
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Icn Biomedicals, Inc.. It received FDA 510(k) clearance on 1992-10-05 under 510(k) number K922376. 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 ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT?

ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT is a medical device that received FDA 510(k) clearance on 1992-10-05. The listed applicant is Icn Biomedicals, Inc.. The 510(k) number is K922376.

When did ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT receive FDA 510(k) clearance?

ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT received FDA 510(k) clearance on 1992-10-05, under 510(k) number K922376.

Who is the listed applicant for ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT?

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

What is the FDA product code for ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT?

The FDA product code for ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT is CGJ.

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Other records listing Icn Biomedicals, Inc. as applicant

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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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