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

Test, Barbiturate, Over The Counter

21 CFR 862.3150 / Clinical Toxicology
FDA source (opens on fda.gov)

PTH is the FDA product code for Test, Barbiturate, Over The Counter, a class II device type, regulated under 21 CFR 862.3150. FDA's definition for this code reads: "The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PTH
Device name
Test, Barbiturate, Over The Counter
FDA definition
The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine.
Regulation
21 CFR 862.3150
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code PTH

By decision year
1 clearance under product code PTH with a decision year between 2018 and 2018, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PTH by decision year
YearClearances
20181

Applicants with the most clearances

Product code PTH
Applicants holding the most 510(k) clearances under product code PTH
ApplicantClearances
Hangzhou Clongene Biotech Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 50 companies shown, in name order