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

Radioimmunoassay, 17-Hydroxyprogesterone

21 CFR 862.1395 / Clinical Chemistry
FDA source (opens on fda.gov)

JLX is the FDA product code for Radioimmunoassay, 17-Hydroxyprogesterone, a class I device type, regulated under 21 CFR 862.1395. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
JLX
Device name
Radioimmunoassay, 17-Hydroxyprogesterone
Regulation
21 CFR 862.1395
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
19
Ingested recalls
3

Clearances, product code JLX

By decision year
19 clearances under product code JLX with a decision year between 1977 and 2010, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JLX by decision year
YearClearances
19771
19841
19861
19881
19892
19912
19942
19951
19981
20042
20051
20071
20081
20091
20101

Applicants with the most clearances

Product code JLX
Applicants holding the most 510(k) clearances under product code JLX
ApplicantClearances
Wallac Oy5
Siemens Healthcare Diagnostics Inc.2
Diagnostic Systems Laboratories, Inc.2
Wien Laboratories, Inc.2
Bio-Rad1
Drg Intl., Inc.1
Icn Biomedicals, Inc.1
Neo-Genesis1
Neometrics, Inc.1
Pantex1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order