RIANEN GENTAMICIN RIA KIT— 510(k) K772425

Substantially Equivalent

New England Nuclear

FDA 510(k) clearance K772425 for RIANEN GENTAMICIN RIA KIT, Substantially Equivalent on 1978-01-05. Applicant: New England Nuclear. Device class: 2.

Clearance details

Applicant: New England Nuclear
Product code: Code DJB
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1977-12-29
Decision date: 1978-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJB

K832792 — AMES TDA SISOMICIN TEST-CONTROL SERUM1983-09-29
K831210 — GENTAMICIN TEST PACK-ACA1983-05-25
K821669 — AMES TDA GENTAMICIN TEST1982-12-15
K812394 — MRI GENTAMICIN RIA KIT1981-09-08
K811844 — COAT-A-COUNT GENTAMICIN RIA KIT1981-07-10

More clearances from New England Nuclear

K841478 — RIANEN CYCLIC-AMP RADIOIMMUNOASSAY1984-06-14
K840301 — RIANEN ESTRIOL RADIOIMMUNOASSAY KIT1984-03-30
K834038 — RIANEN FOLLICLE STIMULATING HORMONE1984-01-30
K833376 — RIANEN LUTEINIZING HORMONE RIA KIT1983-12-20
K831345 — RIANEN PROLACTIN 125I KIT1983-06-08

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