LSK · Class I · 21 CFR 866.3120

FDA Product Code LSK: Dna-reagents, Chlamydia

Leading manufacturers include Gen-Probe, Inc..

8
Total
8
Cleared
252d
Avg days
1987
Since

FDA 510(k) Cleared Dna-reagents, Chlamydia Devices (Product Code LSK)

8 devices
1–8 of 8
Cleared Apr 06, 1994
PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY
K920302
Gen-Probe, Inc.
Microbiology · 806d
Cleared Apr 29, 1992
PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
K920378
Gen-Probe, Inc.
Microbiology · 91d
Cleared Dec 29, 1987
GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS
K874878
Gen-Probe, Inc.
Microbiology · 29d
Cleared Oct 28, 1987
RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS
K871878
Gen-Probe, Inc.
Microbiology · 167d

About Product Code LSK - Regulatory Context