MP TEST— 510(k) K882596

Substantially Equivalent

Diatech Diagnostica , Ltd.

FDA 510(k) clearance K882596 for MP TEST, Substantially Equivalent on 1989-06-21. Applicant: Diatech Diagnostica , Ltd.. Device class: 1.

Clearance details

Applicant: Diatech Diagnostica , Ltd.
Product code: Code LJZ
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1988-06-24
Decision date: 1989-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJZ

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K963054 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)1997-05-05

More clearances from Diatech Diagnostica , Ltd.

K895276 — DIATECH IGM-MP TEST1989-12-18
K882211 — URISCREEN1988-09-30

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