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

Prothrombin Fragment 1.2

21 CFR 864.7320 / Hematology
FDA source (opens on fda.gov)

MIF is the FDA product code for Prothrombin Fragment 1.2, a class II device type, regulated under 21 CFR 864.7320. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MIF
Device name
Prothrombin Fragment 1.2
Regulation
21 CFR 864.7320
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
6
Ingested recalls
0

Clearances, product code MIF

By decision year
6 clearances under product code MIF with a decision year between 1991 and 2004, 1992 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MIF by decision year
YearClearances
19911
19922
19961
19971
20041

Applicants with the most clearances

Product code MIF
Applicants holding the most 510(k) clearances under product code MIF
ApplicantClearances
bioMerieux, Inc.2
Baxter Diagnostics, Inc.1
Behring Diagnostics, Inc.1
Siemens Healthcare Diagnostics Inc.1
Panbio Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code