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

Enzyme Linked Immunoabsorbent Assay, Rubeola Igm

21 CFR 866.3520 / Microbiology
FDA source (opens on fda.gov)

PCL is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Rubeola Igm, a class I device type, regulated under 21 CFR 866.3520. FDA's definition for this code reads: "The qualitative detection of measles specific IgM antibodies in serum or plasma". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 3 recalls.

Classification record

Product code
PCL
Device name
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
FDA definition
The qualitative detection of measles specific IgM antibodies in serum or plasma.
Regulation
21 CFR 866.3520
Device class
Class I
Review panel
Microbiology
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
3

Clearances, product code PCL

By decision year
1 clearance under product code PCL with a decision year between 2014 and 2014, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PCL by decision year
YearClearances
20141

Applicants with the most clearances

Product code PCL
Applicants holding the most 510(k) clearances under product code PCL
ApplicantClearances
Trinity Biotech USA1

Companies listing this code with FDA

Companies whose registered establishments list this code