BARTELS RUBEOLA IGM EIA— 510(k) K922335

Name: FDA 510(k) clearance K922335
Creator: U.S. Food and Drug Administration
Published: 1992-09-02

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K922335 for BARTELS RUBEOLA IGM EIA, Substantially Equivalent on 1992-09-02. Applicant: Baxter Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code LJB
Device class: Class 1
Regulation: 21 CFR 866.3520
Advisory panel: Microbiology
Date received: 1992-05-13
Decision date: 1992-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJB

view all

K974552 — DIAMEDIX IS-MEASLES IGG TEST SYSTEM1998-01-28
K971620 — QUANTA LITE RUBEOLA (MEASLES) IGG1997-07-22
K922330 — BARTELS RUBEOLA IGG EIA1992-09-02
K910290 — VIRATEST-DIA(TM) MEASLES (RUBEOLA)1992-03-18
K904083 — RUBEOLA IGM ELISA TEST1991-01-03

More clearances from Baxter Diagnostics, Inc.

view all

K934458 — DRIED GRAM-POSITIVE MIC/COMBO PANELS1995-07-18
K950817 — DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI1995-04-25
K935704 — DRIED GRAM-NEGATIVE MIC//COMBO PANELS1995-04-14
K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY1995-04-11
K945235 — DRIED GRAM-POSITIVE MIC/COMBO PANELS1995-03-07

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