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FDA 510(k)

IMMOPHASE INSULIN (125I) RADIOASSAY

K-Number: K811953 · 1981-07-23

ApplicantCorning Medical & Scientific
Decision Date1981-07-23
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMOPHASE INSULIN (125I) RADIOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Corning Medical & Scientific. It received FDA 510(k) clearance on 1981-07-23 under 510(k) number K811953. 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 IMMOPHASE INSULIN (125I) RADIOASSAY?

IMMOPHASE INSULIN (125I) RADIOASSAY is a medical device that received FDA 510(k) clearance on 1981-07-23. The listed applicant is Corning Medical & Scientific. The 510(k) number is K811953.

When did IMMOPHASE INSULIN (125I) RADIOASSAY receive FDA 510(k) clearance?

IMMOPHASE INSULIN (125I) RADIOASSAY received FDA 510(k) clearance on 1981-07-23, under 510(k) number K811953.

Who is the listed applicant for IMMOPHASE INSULIN (125I) RADIOASSAY?

The FDA 510(k) record lists Corning Medical & Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMOPHASE INSULIN (125I) RADIOASSAY?

The FDA product code for IMMOPHASE INSULIN (125I) RADIOASSAY is CFP.

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Other records listing Corning Medical & Scientific 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.

K875122DISPOSABLE STERILE SYRINGE FILTERSK872273CORNING EASY WASH ELISA PLATESK872076CORNING DISPOSABLE ROLLER BOTTLESK863789CORNING ELISA PLATESK854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYK853634CORNING CELL WELLS-MULTIPLE WELL PLATES

View all 111 devices →

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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