DIGITOXIN (FPIA) KIT— 510(k) K913240

Substantially Equivalent

Tudor Laboratories, Inc.

FDA 510(k) clearance K913240 for DIGITOXIN (FPIA) KIT, Substantially Equivalent on 1991-09-06. Applicant: Tudor Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Tudor Laboratories, Inc.
Product code: Code LFM
Device class: Class 2
Regulation: 21 CFR 862.3300
Advisory panel: Clinical Toxicology
Date received: 1991-07-22
Decision date: 1991-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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More clearances from Tudor Laboratories, Inc.

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K895571 — N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT1989-10-25
K895567 — PRIMIDONE (FPIA) KIT1989-10-20

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