TPTZ CHLORIDE— 510(k) K820235

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K820235 for TPTZ CHLORIDE, Substantially Equivalent on 1982-02-12. Applicant: American Monitor Corp.. Device class: 2.

Clearance details

Applicant: American Monitor Corp.
Product code: Code CHJ
Device class: Class 2
Regulation: 21 CFR 862.1170
Advisory panel: Clinical Chemistry
Date received: 1982-01-28
Decision date: 1982-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Monitor Corp.

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K895423 — ACCESS CHEMISTRY ANALYZER1989-10-04
K893137 — EXCEL (TM) CHEMISTRY ANALYZER1989-08-10

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