LMD CRYPTOSPORIDIUM ANTIGEN DETECTION— 510(k) K955345

Name: FDA 510(k) clearance K955345
Creator: U.S. Food and Drug Administration
Published: 1996-06-07

Substantially Equivalent

Lmd Laboratories

FDA 510(k) clearance K955345 for LMD CRYPTOSPORIDIUM ANTIGEN DETECTION, Substantially Equivalent on 1996-06-07. Applicant: Lmd Laboratories. Device class: 2.

Clearance details

Applicant: Lmd Laboratories
Product code: Code MHJ
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1995-11-21
Decision date: 1996-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MHJ

view all

K171078 — TRI-COMBO PARASITE SCREEN2017-07-10
K121565 — UNI-GOLD CRYPTOSPORIDIUM2013-02-08
K051929 — GIARDIA/CRYPTOSPORIDIUM CHEK2005-11-17
K052932 — CRYPTOSPORIDIUM II2005-11-04
K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 24510202003-11-14

More clearances from Lmd Laboratories

view all

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
K900780 — CYSTICERCOSIS SEROLOGICAL REAGENTS1990-10-04

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