CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM— 510(k) K955042

Name: FDA 510(k) clearance K955042
Creator: U.S. Food and Drug Administration
Published: 1995-12-13

Substantially Equivalent

Shared Systems, Inc.

FDA 510(k) clearance K955042 for CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM, Substantially Equivalent on 1995-12-13. Applicant: Shared Systems, Inc.. Device class: 2.

Clearance details

Applicant: Shared Systems, Inc.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 1995-11-03
Decision date: 1995-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DCN

view all

K232624 — CardioPhase® hsCRP2023-11-27
K221119 — RCRP Flex reagent cartridge2023-03-17
K192072 — Tina-quant C-Reactive Protein IV2020-02-21
K180099 — Optilite High Sensitivity C-Reactive Protein Kit2018-10-12
K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls2018-02-28

More clearances from Shared Systems, Inc.

view all

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