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

Media And Components, Mycoplasma Detection

21 CFR 864.2360 / Hematology
FDA source (opens on fda.gov)

KPB is the FDA product code for Media And Components, Mycoplasma Detection, a class I device type, regulated under 21 CFR 864.2360. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KPB
Device name
Media And Components, Mycoplasma Detection
Regulation
21 CFR 864.2360
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code KPB

By decision year
4 clearances under product code KPB with a decision year between 1977 and 1978, 1978 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KPB by decision year
YearClearances
19771
19783

Applicants with the most clearances

Product code KPB
Applicants holding the most 510(k) clearances under product code KPB
ApplicantClearances
Flow Laboratories, Inc.3
Bioassay Systems Research Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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