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

Uric Acid Test System For At Home Prescription Use

21 CFR 862.1775 / Clinical Chemistry
FDA source (opens on fda.gov)

PTC is the FDA product code for Uric Acid Test System For At Home Prescription Use, a class I device type, regulated under 21 CFR 862.1775. FDA's definition for this code reads: "For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PTC
Device name
Uric Acid Test System For At Home Prescription Use
FDA definition
For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
Regulation
21 CFR 862.1775
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
2

Clearances, product code PTC

By decision year
3 clearances under product code PTC with a decision year between 2017 and 2025, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PTC by decision year
YearClearances
20171
20181
20251

Applicants with the most clearances

Product code PTC
Applicants holding the most 510(k) clearances under product code PTC
ApplicantClearances
Apex Biotechnology Corp.1
Nova Biomedical Corporation1
Taidoc Technology Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code