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FDA 510(k)

IMMUCHEM COVALENT COAT BINDING

K-Number: K791662 · 1979-09-27

ApplicantImmuchem Corp.
Decision Date1979-09-27
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUCHEM COVALENT COAT BINDING is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1979-09-27 under 510(k) number K791662. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUCHEM COVALENT COAT BINDING?

IMMUCHEM COVALENT COAT BINDING is a medical device that received FDA 510(k) clearance on 1979-09-27. The listed applicant is Immuchem Corp.. The 510(k) number is K791662.

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

IMMUCHEM COVALENT COAT BINDING received FDA 510(k) clearance on 1979-09-27, under 510(k) number K791662.

Who is the listed applicant for IMMUCHEM COVALENT COAT BINDING?

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 BINDING?

The FDA product code for IMMUCHEM COVALENT COAT BINDING is KHQ.

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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: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim 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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