RAICHEM/K.E— 510(k) K854540

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K854540 for RAICHEM/K.E, Substantially Equivalent on 1985-11-26. Applicant: Reagents Applications, Inc.. Device class: 1.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1985-11-13
Decision date: 1985-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJQ

K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM2001-12-21
K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER1998-02-06
K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER1998-02-04
K974762 — STAT TRACKS1998-01-28
K962113 — ANTHOS PHACTS VERSION MICROPLATE READER1996-11-05

More clearances from Reagents Applications, Inc.

K982056 — RAICHEM CO2 REAGENT1998-06-24
K972853 — CHOLESTEROL RAPID LIQUID REAGENT1997-09-24
K922904 — RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II1992-07-30
K915191 — RAI-TROL ELEVATED LIPIDS CONTROL1991-12-18
K913398 — RAICHEM(TM) CREATINE KINASE-MB REAGENT1991-09-25

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