ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)— 510(k) K844141

Name: FDA 510(k) clearance K844141
Creator: U.S. Food and Drug Administration
Published: 1984-12-06

Substantially Equivalent

Lmd Laboratories

FDA 510(k) clearance K844141 for ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC), Substantially Equivalent on 1984-12-06. Applicant: Lmd Laboratories. Device class: 2.

Clearance details

Applicant: Lmd Laboratories
Product code: Code KHW
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1984-10-23
Decision date: 1984-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHW

view all

K170728 — E. HISTOLYTICA QUIK CHEK2017-06-07
K994101 — E. HISTOLYTICA II1999-12-21
K955895 — E. HISTOLYTICA TEST1996-08-30
K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM1996-08-08
K944791 — ENTAMOEBA TEST1995-03-09

More clearances from Lmd Laboratories

view all

K955345 — LMD CRYPTOSPORIDIUM ANTIGEN DETECTION1996-06-07
K942705 — E. COLI 0157 ELISA STOOL ASSAY1995-09-27
K944871 — LMD GIARDIA ANTIGEN DETECTION ASSAY1995-06-22
K905598 — CRYPTOSPORIDIUM ANTIGEN DETECTION1991-09-05
K904613 — TRICHINELLA SEROLOGY MICROTITER ELISA1991-03-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.