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

System, Blood Culturing

21 CFR 866.2560 / Microbiology
FDA source (opens on fda.gov)

MDB is the FDA product code for System, Blood Culturing, a class I device type, regulated under 21 CFR 866.2560. As of , FDA records hold 68 510(k) clearances under this code, the most recent dated , and 76 recalls.

Classification record

Product code
MDB
Device name
System, Blood Culturing
Regulation
21 CFR 866.2560
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
68
Ingested recalls
76

Clearances, product code MDB

By decision year
68 clearances under product code MDB with a decision year between 1981 and 2026, 1996 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code MDB by decision year
YearClearances
19812
19841
19911
19926
19932
19942
19952
19969
19974
19985
19997
20002
20025
20032
20081
20122
20134
20141
20162
20172
20181
20192
20232
20261

Applicants with the most clearances

Product code MDB
Applicants holding the most 510(k) clearances under product code MDB
ApplicantClearances
bioMerieux, Inc.31
Becton Dickinson & Co11
Becton Dickinson Diagnostic Instrument Systems8
BD Becton Dickinson Vacutainer Systems Preanalytic7
Becton Dickinson Microbiology Systems3
Difco Laboratories, Inc.3
Accumed Intl., Inc.1
Lee Laboratories, Inc.1
Marion Laboratories, Inc.1
Oxoid U.S.A., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order