LSK · Class I · 21 CFR 866.3120

FDA Product Code LSK: Dna-reagents, Chlamydia

Leading manufacturers include Gen-Probe, Inc., Digene Corp. and Abbott Molecular, 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 May 28, 2010
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
K092704
Abbott Molecular, Inc.
Microbiology · 267d
Cleared Sep 25, 2001
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
K010891
Digene Corp.
Microbiology · 183d
Cleared Sep 24, 2001
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
K010892
Digene Corp.
Microbiology · 182d
Cleared Oct 25, 1999
HYBRID CAPTURE II CT-ID TEST
K990023
Digene Corp.
Microbiology · 293d
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