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

Dna-Probe, B And T Lymphocyte

21 CFR 864.5220 / Hematology
FDA source (opens on fda.gov)

MAM is the FDA product code for Dna-Probe, B And T Lymphocyte, a class II device type, regulated under 21 CFR 864.5220. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MAM
Device name
Dna-Probe, B And T Lymphocyte
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code MAM

By decision year
1 clearance under product code MAM with a decision year between 1994 and 1994, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MAM by decision year
YearClearances
19941

Applicants with the most clearances

Product code MAM
Applicants holding the most 510(k) clearances under product code MAM
ApplicantClearances
Coulter Electronics, 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 MAM.