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

Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment

21 CFR 866.3720 / Microbiology
FDA source (opens on fda.gov)

LHW is the FDA product code for Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment, a class I device type, regulated under 21 CFR 866.3720. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LHW
Device name
Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
Regulation
21 CFR 866.3720
Device class
Class I
Review panel
Microbiology
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 LHW

By decision year
4 clearances under product code LHW with a decision year between 1981 and 1982, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LHW by decision year
YearClearances
19812
19822

Applicants with the most clearances

Product code LHW
Applicants holding the most 510(k) clearances under product code LHW
ApplicantClearances
Blue Ridge Media Co.2
Dutchland Laboratories, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

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