CMV BRITE TURBO KIT— 510(k) K991650

Substantially Equivalent

Biotest Diagnostics Corp.

FDA 510(k) clearance K991650 for CMV BRITE TURBO KIT, Substantially Equivalent on 1999-07-12. Applicant: Biotest Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Biotest Diagnostics Corp.
Product code: Code LIN
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1999-05-13
Decision date: 1999-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Denville, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIN

K081164 — D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT2008-06-13
K983762 — NUCLISENS CMV PP671999-09-15
K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY1996-06-07
K951550 — CMV BRITE ANTIGENEMIA TEST KIT1996-01-30
K934798 — PATHODX CYTOMEGALOVIRUS1994-03-25

More clearances from Biotest Diagnostics Corp.

K983839 — BIOTEST ANTI-EBV RECOMBINANT1999-06-09
K983841 — BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG1999-06-09
K983842 — BIOTEST ANTI-EBV RECOMBINANT, EA IGM1999-06-09

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