IMMPULSE T4 ASSAY REAGENTS— 510(k) K875081

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K875081 for IMMPULSE T4 ASSAY REAGENTS, Substantially Equivalent on 1988-02-11. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1987-12-09
Decision date: 1988-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-1161993-10-18

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