Product code GSM— Microbiology

SAS BRUCELLA AMS ANTISERUM

Classification name: Antisera, Fluorescent, Brucella Spp.
Device class: Class 2
Regulation: 21 CFR 866.3085
Advisory panel: Microbiology
Total cleared: 4
First cleared: 1995-07-21
Most recent: 1995-07-21

Market context for product code GSM

FDA has cleared 4 devices under product code GSM, all in 1995, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code GSM

Sa Scientific, Inc.4 clearances

Recent clearances under product code GSM

K952132 — SAS BRUCELLA AMS ANTISERUMSa Scientific, Inc.·1995-07-21
K952143 — SAS BRUCELLA MELITENSIS ANTISERUMSa Scientific, Inc.·1995-07-21
K952144 — SAS BRUCELLA SUIS ANTISERUMSa Scientific, Inc.·1995-07-21
K952146 — SAS BRUCELLAS ABORTUS ANTISERUMSa Scientific, Inc.·1995-07-21

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