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

Capillary Blood Collection Device For Alternative Site Collection

21 CFR 862.1675 / Clinical Chemistry
FDA source (opens on fda.gov)

PRJ is the FDA product code for Capillary Blood Collection Device For Alternative Site Collection, a class II device type, regulated under 21 CFR 862.1675. FDA's definition for this code reads: "A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PRJ
Device name
Capillary Blood Collection Device For Alternative Site Collection
FDA definition
A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PRJ

By decision year
2 clearances under product code PRJ with a decision year between 2017 and 2019, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PRJ by decision year
YearClearances
20171
20191

Applicants with the most clearances

Product code PRJ
Applicants holding the most 510(k) clearances under product code PRJ
ApplicantClearances
Seventh Sense Biosystems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code