ENZYMUNE-TEST INSULIN— 510(k) K821374

Substantially Equivalent

Icl Scientific

FDA 510(k) clearance K821374 for ENZYMUNE-TEST INSULIN, Substantially Equivalent on 1982-05-28. Applicant: Icl Scientific. Device class: 1.

Clearance details

Applicant: Icl Scientific
Product code: Code CFP
Device class: Class 1
Regulation: 21 CFR 862.1405
Advisory panel: Clinical Chemistry
Date received: 1982-05-10
Decision date: 1982-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K953084 — ACCESS ULTRASENSITIVE INSULIN ASSAY1995-09-25
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K914820 — DSL INSULIN RIA (DSL 1600)1992-01-09
K903628 — AIA-PACK IRI1990-09-07

More clearances from Icl Scientific

K883942 — HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL1988-11-10
K843565 — KOVA TROL I,II, III HUMAN URINE-DRIED1984-10-05
K833761 — THERAPEUTIC DRUG CONTROL1984-01-13
K832823 — ENZYMUNE-TEST TSH1983-10-14
K831383 — EVENT-TEST SLIDE1983-06-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.