MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY— 510(k) K982709

Name: FDA 510(k) clearance K982709
Creator: U.S. Food and Drug Administration
Published: 1998-09-03

Substantially Equivalent

Alexon - Trend, Inc.

FDA 510(k) clearance K982709 for MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY, Substantially Equivalent on 1998-09-03. Applicant: Alexon - Trend, Inc.. Device class: 2.

Clearance details

Applicant: Alexon - Trend, Inc.
Product code: Code MHJ
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1998-08-04
Decision date: 1998-09-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Ramsey, MN, 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 Alexon - Trend, Inc.

view all

K982315 — PROSPECT CAMPYLOBACTER MICROPLATE ASSAY1998-11-18
K980507 — PROSPECT SHIGA TOXIN MICROPLATE ASSAY1998-04-23

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