RIA, DIGNXIN-125-I— 510(k) K790602

Substantially Equivalent

Endocrine-Metabolic Center

FDA 510(k) clearance K790602 for RIA, DIGNXIN-125-I, Substantially Equivalent on 1979-07-30. Applicant: Endocrine-Metabolic Center. Device class: 2.

Clearance details

Applicant: Endocrine-Metabolic Center
Product code: Code DPB
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1979-03-27
Decision date: 1979-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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 Endocrine-Metabolic Center

K821131 — RADIOIMMUNOASSAY PARATHYROID HORMONE MID1982-06-02
K811993 — RADIOIMMUNOASSAY, FOLLICLE STIMULATING1981-08-03
K811994 — RADIOIMMUNOASSAY LUTEINIZING HORMONE1981-07-27
K810948 — RADIOIMMUNOASSAY THYROID STIM. HORM. KIT1981-04-17
K810351 — RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE1981-02-23

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