GRY · Class II · 21 CFR 866.3350

FDA Product Code GRY: Antigens, All, Leptospira Spp.

Leading manufacturers include Panbio, Inc. and Hillcrest Biologicals.

2
Total
2
Cleared
107d
Avg days
1988
Since

FDA 510(k) Cleared Antigens, All, Leptospira Spp. Devices (Product Code GRY)

2 devices
1–2 of 2
Cleared Nov 22, 2000
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
K002024
Panbio, Inc.
Microbiology · 142d
Cleared Apr 12, 1988
LEPTOSPIROSIS IHA
K880417
Hillcrest Biologicals
Microbiology · 71d

About Product Code GRY - Regulatory Context