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

Gram-Positive Bacteria And Their Resistance Markers

21 CFR 866.3365 / Microbiology
FDA source (opens on fda.gov)

PAM is the FDA product code for Gram-Positive Bacteria And Their Resistance Markers, a class II device type, regulated under 21 CFR 866.3365. FDA's definition for this code reads: "A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
PAM
Device name
Gram-Positive Bacteria And Their Resistance Markers
FDA definition
A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Regulation
21 CFR 866.3365
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
11

Clearances, product code PAM

By decision year
7 clearances under product code PAM with a decision year between 2012 and 2026, 2012 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PAM by decision year
YearClearances
20122
20161
20171
20181
20251
20261

Applicants with the most clearances

Product code PAM
Applicants holding the most 510(k) clearances under product code PAM
ApplicantClearances
Luminex Corporation3
Genmark Diagnostics, Incorporated1
Great Basin Scientific, Inc.1
Icubate, Inc.1
Qiagen1

Companies listing this code with FDA

Companies whose registered establishments list this code