125I DIGOXIN TEST SET— 510(k) K772306

Substantially Equivalent

Wien Laboratories, Inc.

FDA 510(k) clearance K772306 for 125I DIGOXIN TEST SET, Substantially Equivalent on 1977-12-22. Applicant: Wien Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Wien Laboratories, Inc.
Product code: Code DPB
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1977-12-15
Decision date: 1977-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPB

K853021 — OPTIMATE DIGOXIN TEST1985-08-07
K823014 — DIGOXIN KIT1982-11-01
K821811 — 125I DIGOXIN RADIOIMMUNOASSAY KIT1982-07-02
K820274 — DIGOXIN RADIOIMMUNOASSAY1982-02-23
K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEM1979-11-13

More clearances from Wien Laboratories, Inc.

K912850 — SHBG1991-08-12
K834246 — PROGESTERONE TEST SET 125I 17-OH1984-02-04
K832452 — ANDROSTENEDIONE TEST SET 125I1983-09-12
K823200 — 125 I-DEHYDROEPIANDROSTERONE SULFATE1982-11-29
K821652 — DOXEPIN TRI-CY TEST SET1982-06-14

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