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

Dna-Probe, Strep Pneumoniae

21 CFR 866.3740 / Microbiology
FDA source (opens on fda.gov)

MCT is the FDA product code for Dna-Probe, Strep Pneumoniae, a class I device type, regulated under 21 CFR 866.3740. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MCT
Device name
Dna-Probe, Strep Pneumoniae
Regulation
21 CFR 866.3740
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
0

Clearances, product code MCT

By decision year
1 clearance under product code MCT with a decision year between 1990 and 1990, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MCT by decision year
YearClearances
19901

Applicants with the most clearances

Product code MCT
Applicants holding the most 510(k) clearances under product code MCT
ApplicantClearances
Hologic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MCT.