HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)— 510(k) K902155

Name: FDA 510(k) clearance K902155
Creator: U.S. Food and Drug Administration
Published: 1990-06-12

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K902155 for HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964), Substantially Equivalent on 1990-06-12. Applicant: Hichem Diagnostics. Device class: 2.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code JIM
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1990-05-15
Decision date: 1990-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIM

view all

K790772 — CHEMTAB1979-06-15

More clearances from Hichem Diagnostics

view all

K981794 — HICHEM CALCIUM REAGENT KIT1998-07-29
K963383 — HICHEM ALP/AMP REAGENT KIT1996-09-23
K953860 — HICHEM ISE DILUENT KIT 700081995-09-06
K953861 — HICHEM ISE INTDERNAL REFERENCE KIT 700091995-09-06
K953862 — HICHEM ISEKCI SOLUTION KIT 700101995-09-06

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