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FDA 510(k)

COVALENT COAT RIA KIT

K-Number: K822509 · 1982-09-28

ApplicantImmuchem Corp.
Decision Date1982-09-28
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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 1982-09-28 under 510(k) number K822509. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVALENT COAT RIA KIT?

COVALENT COAT RIA KIT is a medical device that received FDA 510(k) clearance on 1982-09-28. The listed applicant is Immuchem Corp.. The 510(k) number is K822509.

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

COVALENT COAT RIA KIT received FDA 510(k) clearance on 1982-09-28, under 510(k) number K822509.

Who is the listed applicant for 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 COVALENT COAT RIA KIT?

The FDA product code for COVALENT COAT RIA KIT is CFP.

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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: CFP)

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.

K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer 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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