ZETAPHASE-DIG— 510(k) K822053

Substantially Equivalent

Biological & Diagnostic Products

FDA 510(k) clearance K822053 for ZETAPHASE-DIG, Substantially Equivalent on 1982-07-27. Applicant: Biological & Diagnostic Products. Device class: 2.

Clearance details

Applicant: Biological & Diagnostic Products
Product code: Code DON
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1982-07-13
Decision date: 1982-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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
K821000 — ENZYMUNE-TEST DIGOXIN1982-04-26

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