510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JJAClass I

Radio-Labeled Iron Method, Iron (Non-Heme)

21 CFR 862.1410 / Clinical Chemistry
FDA source (opens on fda.gov)

JJA is the FDA product code for Radio-Labeled Iron Method, Iron (Non-Heme), a class I device type, regulated under 21 CFR 862.1410. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JJA
Device name
Radio-Labeled Iron Method, Iron (Non-Heme)
Regulation
21 CFR 862.1410
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code JJA

By decision year
4 clearances under product code JJA with a decision year between 1976 and 1982, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JJA by decision year
YearClearances
19761
19781
19791
19821

Applicants with the most clearances

Product code JJA
Applicants holding the most 510(k) clearances under product code JJA
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Diagnostic Reagents, Inc.1
Leeco Diagnostics, Inc.1
Ria Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code JJA.