NABI CRP-Q.S. TEST— 510(k) K834584

Substantially Equivalent

Intl. Diagnostic, Inc.

FDA 510(k) clearance K834584 for NABI CRP-Q.S. TEST, Substantially Equivalent on 1984-02-27. Applicant: Intl. Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic, Inc.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 1983-12-29
Decision date: 1984-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DCN

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 Intl. Diagnostic, Inc.

K841853 — PREG-BETA ONE HOUR TUBE TEST1984-06-22
K840833 — PREG BETA BLUS SLIDE1984-05-30
K840005 — NABI RF-Q.S. TEST1984-02-13
K802343 — PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO1980-10-10
K780321 — PREGNANCY TEST KIT, OVER-THE-COUNTER1978-04-04

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