BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY— 510(k) K802581

Name: FDA 510(k) clearance K802581
Creator: U.S. Food and Drug Administration
Published: 1980-11-12

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K802581 for BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY, Substantially Equivalent on 1980-11-12. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code JFJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1980-10-20
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFJ

view all

K210633 — Amylase22022-05-26
K191454 — Atellica CH Amylase_2 (AMY_2)2019-07-30
K182474 — alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL2019-05-02
K130685 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY2013-08-09
K122858 — ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II2012-10-03

More clearances from Beckman Instruments, Inc.

view all

K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 344691998-09-17
K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER1998-07-14
K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT1998-05-08
K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 332111998-05-01
K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 335051998-03-18

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