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FDA 510(k)

ANDROSTENEDIONE 125I KIT BY RIA

K-Number: K860559 · 1986-03-14

ApplicantImmuchem Corp.
Decision Date1986-03-14
Product CodeCIZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANDROSTENEDIONE 125I KIT BY RIA is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1986-03-14 under 510(k) number K860559. The device is classified under product code CIZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANDROSTENEDIONE 125I KIT BY RIA?

ANDROSTENEDIONE 125I KIT BY RIA is a medical device that received FDA 510(k) clearance on 1986-03-14. The listed applicant is Immuchem Corp.. The 510(k) number is K860559.

When did ANDROSTENEDIONE 125I KIT BY RIA receive FDA 510(k) clearance?

ANDROSTENEDIONE 125I KIT BY RIA received FDA 510(k) clearance on 1986-03-14, under 510(k) number K860559.

Who is the listed applicant for ANDROSTENEDIONE 125I KIT BY RIA?

The FDA 510(k) record lists Immuchem Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANDROSTENEDIONE 125I KIT BY RIA?

The FDA product code for ANDROSTENEDIONE 125I KIT BY RIA is CIZ.

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Other records listing Immuchem Corp. 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.

K883726THYROID STIMULATING HORMONE (HTSH) IRMA NEONATALK871317FOLLICLE STIMULATING HORMONE (HFSH)K871542HPROLACTIN KITK865071THYROID STIMULATING HORMONE (TSH IRMA) RIA KITK864144LUTEINIZING HORMONE (LH-IRMA) RIA KITK854094IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS

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Related Devices (Code: CIZ)

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.

K963002ACTIVE ANDROSTENEDIONE EIADiagnostic Systems Laboratories, Inc.K954755COAT-A-COUNT DIRECT ANDROSTENEDIONEDiagnostic Products Corp.K934751ACTIVE ANDROSTANEDIOL GLUCURONIDEDiagnostic Systems Laboratories, Inc.K854673DSL ANDROSTENEDIONE RIA (DSL # 4200)Diagnostic Systems Laboratories, Inc.K854650DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)Diagnostic Systems Laboratories, Inc.K844398COAT-A-COUNT ANDROSTENEDIONE RIA KITDiagnostic Products Corp.

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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