ACA DATA MATE ACCESSORY— 510(k) K760739

Name: FDA 510(k) clearance K760739
Creator: U.S. Food and Drug Administration
Published: 1976-11-16

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K760739 for ACA DATA MATE ACCESSORY, Substantially Equivalent on 1976-11-16. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JQP
Device class: Class 1
Regulation: 21 CFR 862.2100
Advisory panel: Clinical Chemistry
Date received: 1976-09-29
Decision date: 1976-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K953724 — CRONEX RADIATION THERAPY CASSETTE1995-09-06
K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTE1995-09-06
K951441 — DUPONT ACA DIGOXIN (DGN A) METHOD1995-06-01
K950137 — URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE1995-04-13

Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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