RIA, DIGOXIN— 510(k) K781660

Substantially Equivalent

E. R. Squibb & Sons, Inc.

FDA 510(k) clearance K781660 for RIA, DIGOXIN, Substantially Equivalent on 1978-10-24. Applicant: E. R. Squibb & Sons, Inc.. Device class: 2.

Clearance details

Applicant: E. R. Squibb & Sons, Inc.
Product code: Code DON
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1978-09-28
Decision date: 1978-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DON

K902861 — CIBA CORNING ACS DIGOXIN IMMUNOASSAY1990-09-10
K881679 — CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY1988-07-08
K840461 — MAGIC 125I DIGOXIN RADIOIMMUNOASSAY1984-03-23
K830533 — PHASE II DIGOXIN RADIOIMMUNOASSAY KIT1983-04-05
K822053 — ZETAPHASE-DIG1982-07-27

More clearances from E. R. Squibb & Sons, Inc.

K821494 — RIA STAT 161982-06-03
K820616 — ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY1982-03-26
K820340 — T3 UPTAKE-SQUIBB DIAGNOSTIC KIT1982-03-04
K820341 — CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT1982-03-04
K811240 — SUR-FIT LOOP OSTOMY O.R. SET1981-06-16

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