Medical Device Manufacturer · US , Columbia , MD

Stellar Bio Systems, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1988

Recent clearances: EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM, INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY, INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Stellar Bio Systems, Inc. Microbiology ✕

5 devices

1-5 of 5

Cleared Dec 22, 1999

EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM

Microbiology · 142d

Cleared Feb 19, 1992

IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY

Microbiology · 106d

Cleared Nov 07, 1991

INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1

Microbiology · 328d

Cleared Apr 16, 1990

INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.

Microbiology · 45d

Cleared Dec 05, 1988

INDIRECT FLUORESCENT ASSAY FOR (HCMV)

Microbiology · 150d