510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LHJClass I

Staphylococcus Aureus Protein A Insoluble

21 CFR 866.3700 / Microbiology
FDA source (opens on fda.gov)

LHJ is the FDA product code for Staphylococcus Aureus Protein A Insoluble, a class I device type, regulated under 21 CFR 866.3700. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LHJ
Device name
Staphylococcus Aureus Protein A Insoluble
Regulation
21 CFR 866.3700
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
3
Ingested recalls
2

Clearances, product code LHJ

By decision year
3 clearances under product code LHJ with a decision year between 1981 and 1994, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LHJ by decision year
YearClearances
19811
19841
19941

Applicants with the most clearances

Product code LHJ
Applicants holding the most 510(k) clearances under product code LHJ
ApplicantClearances
Immucell Corp.1
Oxoid U.S.A., Inc.1
Unipath, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code