CO2 CUP REAGENT— 510(k) K791686

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K791686 for CO2 CUP REAGENT, Substantially Equivalent on 1979-09-17. Applicant: Hi Chem, Inc.. Device class: 2.

Clearance details

Applicant: Hi Chem, Inc.
Product code: Code JFL
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1979-07-31
Decision date: 1979-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K941764 — HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 888081994-05-13
K902673 — HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND1990-07-17

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