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FDA 510(k)

IMMUCHEM COVALENT-COAT

K-Number: K822140 · 1982-08-05

ApplicantImmuchem Corp.
Decision Date1982-08-05
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUCHEM COVALENT-COAT is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1982-08-05 under 510(k) number K822140. The device is classified under product code JKC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUCHEM COVALENT-COAT?

IMMUCHEM COVALENT-COAT is a medical device that received FDA 510(k) clearance on 1982-08-05. The listed applicant is Immuchem Corp.. The 510(k) number is K822140.

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

IMMUCHEM COVALENT-COAT received FDA 510(k) clearance on 1982-08-05, under 510(k) number K822140.

Who is the listed applicant for IMMUCHEM COVALENT-COAT?

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?

The FDA product code for IMMUCHEM COVALENT-COAT is JKC.

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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: JKC)

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.

K040181ACCESS DHEA-S REAGENT ASSAYBeckman Coulter, Inc.K003174ELECSYS DHEA-SRoche Diagnostics Corp.K973897DHEA-SKmi Diagnostics, Inc.K962895DSL DHEA-S-7Diagnostic Systems Laboratories, Inc.K955114DSL AACTIVE DHEA EIA KITDiagnostic Systems Laboratories, Inc.K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYNichols Institute

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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