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FDA 510(k)

IMMUCHEM COVALENT COAT SOLID PHASE ASSAY

K-Number: K791663 · 1979-10-01

ApplicantImmuchem Corp.
Decision Date1979-10-01
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUCHEM COVALENT COAT SOLID PHASE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1979-10-01 under 510(k) number K791663. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUCHEM COVALENT COAT SOLID PHASE ASSAY?

IMMUCHEM COVALENT COAT SOLID PHASE ASSAY is a medical device that received FDA 510(k) clearance on 1979-10-01. The listed applicant is Immuchem Corp.. The 510(k) number is K791663.

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

IMMUCHEM COVALENT COAT SOLID PHASE ASSAY received FDA 510(k) clearance on 1979-10-01, under 510(k) number K791663.

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

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 SOLID PHASE ASSAY?

The FDA product code for IMMUCHEM COVALENT COAT SOLID PHASE ASSAY is CDP.

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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: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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