RUBEOLA IGG ELISA TEST— 510(k) K904854

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K904854 for RUBEOLA IGG ELISA TEST, Substantially Equivalent on 1990-12-04. Applicant: Gull Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code LJB
Device class: Class 1
Regulation: 21 CFR 866.3520
Advisory panel: Microbiology
Date received: 1990-10-29
Decision date: 1990-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJB

K974552 — DIAMEDIX IS-MEASLES IGG TEST SYSTEM1998-01-28
K971620 — QUANTA LITE RUBEOLA (MEASLES) IGG1997-07-22
K922330 — BARTELS RUBEOLA IGG EIA1992-09-02
K922335 — BARTELS RUBEOLA IGM EIA1992-09-02
K910290 — VIRATEST-DIA(TM) MEASLES (RUBEOLA)1992-03-18

More clearances from Gull Laboratories, Inc.

K983541 — HSV 1+2 IGG ELISA TEST1999-02-26
K971857 — MUMPS IGG ELISA TESTY1997-11-04
K962343 — TOXO IGG ELISA TEST1997-03-24
K935730 — EBNA IGG ELISA TEST1995-09-19
K940093 — EBV-EA(D) IGG ELISA TEST1995-09-15

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