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

Radioimmunoassay, Progesterone

21 CFR 862.1620 / Clinical Chemistry
FDA source (opens on fda.gov)

JLS is the FDA product code for Radioimmunoassay, Progesterone, a class I device type, regulated under 21 CFR 862.1620. As of , FDA records hold 57 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
JLS
Device name
Radioimmunoassay, Progesterone
Regulation
21 CFR 862.1620
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
57
Ingested recalls
21

Clearances, product code JLS

By decision year
57 clearances under product code JLS with a decision year between 1977 and 2004, 1993 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JLS by decision year
YearClearances
19771
19794
19802
19814
19822
19832
19843
19853
19864
19873
19882
19894
19913
19922
19935
19942
19953
19962
19975
20041

Applicants with the most clearances

Product code JLS
Applicants holding the most 510(k) clearances under product code JLS
ApplicantClearances
Amersham Corp.4
Siemens Healthcare Diagnostics Inc.4
Baxter Diagnostics, Inc.2
BD Becton Dickinson Vacutainer Systems Preanalytic2
Biotecx Laboratories, Inc.2
Boehringer Mannheim Corp.2
Diagnostic Systems Laboratories, Inc.2
Immuchem Corp.2
bioMerieux, Inc.2
Radioassay Systems Laboratories, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order