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

Hemoglobin C (Abnormal Hemoglobin Variant)

21 CFR 864.7415 / Hematology
FDA source (opens on fda.gov)

MLL is the FDA product code for Hemoglobin C (Abnormal Hemoglobin Variant), a class II device type, regulated under 21 CFR 864.7415. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MLL
Device name
Hemoglobin C (Abnormal Hemoglobin Variant)
Regulation
21 CFR 864.7415
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 MLL

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

Applicants with the most clearances

Product code MLL
Applicants holding the most 510(k) clearances under product code MLL
ApplicantClearances
Isolab, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code