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FDA 510(k)

IMX INSULIN

K-Number: K920109 · 1992-05-07

ApplicantAbbott Laboratories
Decision Date1992-05-07
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMX INSULIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1992-05-07 under 510(k) number K920109. 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 IMX INSULIN?

IMX INSULIN is a medical device that received FDA 510(k) clearance on 1992-05-07. The listed applicant is Abbott Laboratories. The 510(k) number is K920109.

When did IMX INSULIN receive FDA 510(k) clearance?

IMX INSULIN received FDA 510(k) clearance on 1992-05-07, under 510(k) number K920109.

Who is the listed applicant for IMX INSULIN?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMX INSULIN?

The FDA product code for IMX INSULIN is CFP.

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Other records listing Abbott Laboratories 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.

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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.K914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim Corp.K896572REP(TM) SPE PLUS-30 PROCEDURESHelena Laboratories

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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