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FDA 510(k)

IMMUCHEM COVALENT-COAT RIA KIT

K-Number: K830962 · 1983-05-04

ApplicantImmuchem Corp.
Decision Date1983-05-04
Product CodeDPO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMUCHEM COVALENT-COAT RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1983-05-04 under 510(k) number K830962. The device is classified under product code DPO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUCHEM COVALENT-COAT RIA KIT?

IMMUCHEM COVALENT-COAT RIA KIT is a medical device that received FDA 510(k) clearance on 1983-05-04. The listed applicant is Immuchem Corp.. The 510(k) number is K830962.

When did IMMUCHEM COVALENT-COAT RIA KIT receive FDA 510(k) clearance?

IMMUCHEM COVALENT-COAT RIA KIT received FDA 510(k) clearance on 1983-05-04, under 510(k) number K830962.

Who is the listed applicant for IMMUCHEM COVALENT-COAT RIA KIT?

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 RIA KIT?

The FDA product code for IMMUCHEM COVALENT-COAT RIA KIT is DPO.

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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 KITK860559ANDROSTENEDIONE 125I KIT BY RIA

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Related Devices (Code: DPO)

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.

K914833IMMULITE DIGOXINCirrus Diagnostics, Inc.K905719ECLIPSE ICA DIGOXINBiotope, Inc.K864449DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KITCanadian Bioclinical, Ltd.K833842RIA COAT DIGOXINImmuno Assay Corp.K832163SOPHEIA DIGOXIN EIA KITDiagnostic Products Corp.K811932COAT-A-COUNT DIGOXIN RIADiagnostic 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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