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

Spectrophotometric Method, Pregnanediol

21 CFR 862.1605 / Clinical Chemistry
FDA source (opens on fda.gov)

JLP is the FDA product code for Spectrophotometric Method, Pregnanediol, a class I device type, regulated under 21 CFR 862.1605. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
JLP
Device name
Spectrophotometric Method, Pregnanediol
Regulation
21 CFR 862.1605
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
1
Ingested recalls
0

Clearances, product code JLP

By decision year
1 clearance under product code JLP with a decision year between 1988 and 1988, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JLP by decision year
YearClearances
19881

Applicants with the most clearances

Product code JLP
Applicants holding the most 510(k) clearances under product code JLP
ApplicantClearances
Boots-Celltech Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code