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
LHTClass I

Staphylococcus Aureus Somatic Antigens

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

LHT is the FDA product code for Staphylococcus Aureus Somatic Antigens, a class I device type, regulated under 21 CFR 866.3700. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LHT
Device name
Staphylococcus Aureus Somatic Antigens
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
13
Ingested recalls
0

Clearances, product code LHT

By decision year
13 clearances under product code LHT with a decision year between 1981 and 1987, 1981 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code LHT by decision year
YearClearances
19818
19823
19861
19871

Applicants with the most clearances

Product code LHT
Applicants holding the most 510(k) clearances under product code LHT
ApplicantClearances
Dutchland Laboratories, Inc.7
American Scientific Products1
Carr-Scarborough Microbiologicals, Inc.1
Diagnostica, Inc.1
Meridian Diagnostics, Inc.1
Oxoid U.S.A., Inc.1
Scott Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code