Product code JJA— Clinical Chemistry

DIAGNOSTIC KIT, FERRITAB-FE-59

Classification name: Radio-Labeled Iron Method, Iron (Non-Heme)
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Total cleared: 4
First cleared: 1976-07-20
Most recent: 1982-05-12

Market context for product code JJA

FDA has cleared 4 devices under product code JJA between 1976 and 1982, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19821 clearance
19791 clearance
19781 clearance
19761 clearance

Top applicants under product code JJA

Ria Products, Inc.1 clearance
Leeco Diagnostics, Inc.1 clearance
Diagnostic Reagents, Inc.1 clearance
Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

Recent clearances under product code JJA

K820253 — SIMUL-FER SERUM IRON TEST KITDiagnostic Reagents, Inc.·1982-05-12
K782159 — DIAGNOSTIC KIT, FERRITAB-FE-59Leeco Diagnostics, Inc.·1979-02-01
K781769 — IRON 59 KITRia Products, Inc.·1978-12-04
K760045 — KIT, RADIOASSAY, SERUM IRONBd Becton Dickinson Vacutainer Systems Preanalytic·1976-07-20

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