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

Test, Screening, For D Positive Fetal Rbc'S

21 CFR 864.7455 / Hematology
FDA source (opens on fda.gov)

LIM is the FDA product code for Test, Screening, For D Positive Fetal Rbc'S, a class II device type, regulated under 21 CFR 864.7455. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LIM
Device name
Test, Screening, For D Positive Fetal Rbc'S
Regulation
21 CFR 864.7455
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
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code LIM

By decision year
2 clearances under product code LIM with a decision year between 1982 and 1998, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LIM by decision year
YearClearances
19821
19981

Applicants with the most clearances

Product code LIM
Applicants holding the most 510(k) clearances under product code LIM
ApplicantClearances
Biopool Intl., Inc.1
Gamma Biologicals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code