CMV BIO-BEAD SCREEN KIT— 510(k) K791612

Substantially Equivalent

Litton Bionetics

FDA 510(k) clearance K791612 for CMV BIO-BEAD SCREEN KIT, Substantially Equivalent on 1979-11-13. Applicant: Litton Bionetics. Device class: 2.

Clearance details

Applicant: Litton Bionetics
Product code: Code GQH
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1979-08-21
Decision date: 1979-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code GQH

K982311 — BARTELS CINAKIT CMV ANTIGENEMIA1998-12-14
K964875 — CMV ANTIGEN CONTROL SLIDES1997-03-18
K935809 — CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY1994-05-05
K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV)1988-12-05
K882024 — FITC MURINE MONOCLONAL ANTI-CMV IGG1988-08-03

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
K822985 — EBV-M KIT1982-12-03
K821804 — RUBELLA RQ BIO-ENZABEAD KIT1982-09-14

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