TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)— 510(k) K884747

Name: FDA 510(k) clearance K884747
Creator: U.S. Food and Drug Administration
Published: 1989-01-30

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K884747 for TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL), Substantially Equivalent on 1989-01-30. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CKB
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1988-11-14
Decision date: 1989-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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