DIGOXIN EIA KIT— 510(k) K801490

Substantially Equivalent

M.A. Bioproducts

FDA 510(k) clearance K801490 for DIGOXIN EIA KIT, Substantially Equivalent on 1980-07-14. Applicant: M.A. Bioproducts. Device class: 2.

Clearance details

Applicant: M.A. Bioproducts
Product code: Code LCS
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1980-06-26
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code LCS

K922353 — DIGOXIN COATED TUBE RIA1992-08-24
K913562 — QMS - DIGOXIN1991-08-30
K895828 — INNOFLUOR DIGOXIN REAGENT SET1989-10-30
K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT1989-01-17
K874748 — IMMPULSE DIGOXIN ASSAY REAGENTS1988-02-19

More clearances from M.A. Bioproducts

K822883 — HERPELISA KIT1983-07-26
K823804 — MYCOPLASMELISA TEST KIT1983-05-25
K830045 — MUMPSELISA TEST KIT1983-05-13
K830615 — CYTOMEGELISA STAT1983-05-09
K823805 — VARICELISA TEST KIT1983-05-05

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