ASTRA PRINTER PAPER #88112-CHLORIDE SILV— 510(k) K802392

Name: FDA 510(k) clearance K802392
Creator: U.S. Food and Drug Administration
Published: 1980-10-23

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K802392 for ASTRA PRINTER PAPER #88112-CHLORIDE SILV, Substantially Equivalent on 1980-10-23. Applicant: Hi Chem, Inc.. Device class: 1.

Clearance details

Applicant: Hi Chem, Inc.
Product code: Code JJF
Device class: Class 1
Regulation: 21 CFR 862.2170
Advisory panel: Clinical Chemistry
Date received: 1980-10-02
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJF

view all

K052794 — ETI-MAX 30002006-03-31
K040332 — POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER2004-06-16
K033734 — LIGHTCYCLER INSTRUMENT VERSION 1.22003-12-17
K013654 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER2002-06-05
K012966 — ROCHE COBAS TAQMAN ANALYZER2002-02-01

More clearances from Hi Chem, Inc.

view all

K960084 — HICHEM GLUCOSE/HK REAGENT KIT1996-04-04
K951818 — HICHEM ALT REAGENT KIT1995-05-15
K943684 — HICHEM ENZYME VERIFIER KIT1994-10-04
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

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