EBV-M KIT— 510(k) K822985

Substantially Equivalent

Litton Bionetics

FDA 510(k) clearance K822985 for EBV-M KIT, Substantially Equivalent on 1982-12-03. Applicant: Litton Bionetics. Device class: 1.

Clearance details

Applicant: Litton Bionetics
Product code: Code JRY
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1982-10-12
Decision date: 1982-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code JRY

K042118 — ATHENA MULTI-LYTE EBV IGG TEST SYSTEM2005-04-29
K900974 — INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.1990-04-16
K891785 — BION EBV-G (VCA) TEST SYSTEM1989-08-31
K884829 — EBV EARLY ANTIGEN (R+D)1989-04-12
K822734 — EBV IGM TEST1982-12-09

More clearances from Litton Bionetics

K840417 — EBNA ACIF KIT1984-12-27
K834443 — ROTAVIRUS BIO-ENZABEAD SCREEN KIT1984-03-16
K831343 — CMV RQ BIO-ENZABEAD KIT1983-08-08
K821804 — RUBELLA RQ BIO-ENZABEAD KIT1982-09-14
K801720 — TOXO BIO-BEAD TITRATION KIT1980-09-16

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