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FDA 510(k)

IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS

K-Number: K854094 · 1986-02-28

ApplicantImmuchem Corp.
Decision Date1986-02-28
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1986-02-28 under 510(k) number K854094. The device is classified under product code JLS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS?

IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Immuchem Corp.. The 510(k) number is K854094.

When did IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS receive FDA 510(k) clearance?

IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS received FDA 510(k) clearance on 1986-02-28, under 510(k) number K854094.

Who is the listed applicant for IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS?

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 IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS?

The FDA product code for IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS is JLS.

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Other records listing Immuchem Corp. as applicant

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K883726THYROID STIMULATING HORMONE (HTSH) IRMA NEONATALK871317FOLLICLE STIMULATING HORMONE (HFSH)K871542HPROLACTIN KITK865071THYROID STIMULATING HORMONE (TSH IRMA) RIA KITK864144LUTEINIZING HORMONE (LH-IRMA) RIA KITK860559ANDROSTENEDIONE 125I KIT BY RIA

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Related Devices (Code: JLS)

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.

K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbHK973898PROGESTERONE ELISAKmi Diagnostics, Inc.K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)Johnson & Johnson Clinical Diagnostics, Inc.K971725OPUS PROGESTERONEBehring Diagnostics, Inc.K964841ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.K965084VIDAS PROESTERONE (PRG) (30 409)bioMerieux, 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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