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FDA 510(k)

ENZYMUNE-TEST INSULIN

K-Number: K821374 · 1982-05-28

ApplicantIcl Scientific
Decision Date1982-05-28
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMUNE-TEST INSULIN is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821374. 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 ENZYMUNE-TEST INSULIN?

ENZYMUNE-TEST INSULIN is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Icl Scientific. The 510(k) number is K821374.

When did ENZYMUNE-TEST INSULIN receive FDA 510(k) clearance?

ENZYMUNE-TEST INSULIN received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821374.

Who is the listed applicant for ENZYMUNE-TEST INSULIN?

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

What is the FDA product code for ENZYMUNE-TEST INSULIN?

The FDA product code for ENZYMUNE-TEST INSULIN is CFP.

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Other records listing Icl 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.

K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLK843565KOVA TROL I,II, III HUMAN URINE-DRIEDK833761THERAPEUTIC DRUG CONTROLK832823ENZYMUNE-TEST TSHK831383EVENT-TEST SLIDEK823199ENZYME-TEST DIGOXIN

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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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