IMMPULSE DIGOXIN ASSAY REAGENTS— 510(k) K874748

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K874748 for IMMPULSE DIGOXIN ASSAY REAGENTS, Substantially Equivalent on 1988-02-19. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code LCS
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1987-11-18
Decision date: 1988-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT1989-01-17
K864802 — DART DIGOXIN ASSAY1987-02-12

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K895822 — TOTAL BILIRUBIN L.F.1989-11-14

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