BUN REAGENT KIT— 510(k) K873132

Substantially Equivalent

A-Kem, Inc.

FDA 510(k) clearance K873132 for BUN REAGENT KIT, Substantially Equivalent on 1987-10-23. Applicant: A-Kem, Inc.. Device class: 2.

Clearance details

Applicant: A-Kem, Inc.
Product code: Code LFP
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1987-08-10
Decision date: 1987-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clifton, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from A-Kem, Inc.

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K884227 — CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM1988-12-09
K882586 — A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM1988-08-08

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