RUBELLA BIO-BEAD SCREEN KIT— 510(k) K791610

Substantially Equivalent

Litton Bionetics

FDA 510(k) clearance K791610 for RUBELLA BIO-BEAD SCREEN KIT, Substantially Equivalent on 1979-11-13. Applicant: Litton Bionetics. Device class: 2.

Clearance details

Applicant: Litton Bionetics
Product code: Code GOL
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1979-08-21
Decision date: 1979-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GOL

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K834032 — RUBAQUICK DIAGNOSTIC KIT1984-04-17
K810309 — RUBELLA ANTIBODIES TEST REAGENTS1981-03-11
K802102 — RUBELLA ELISA REAGENTS RUBELLA IGG ANTI1980-12-18
K802339 — EIA RUBELLA-G1980-12-18

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.