510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LSKClass I

Dna-Reagents, Chlamydia

21 CFR 866.3120 / Microbiology
FDA source (opens on fda.gov)

LSK is the FDA product code for Dna-Reagents, Chlamydia, a class I device type, regulated under 21 CFR 866.3120. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LSK
Device name
Dna-Reagents, Chlamydia
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
1

Clearances, product code LSK

By decision year
8 clearances under product code LSK with a decision year between 1987 and 2010, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LSK by decision year
YearClearances
19872
19921
19941
19991
20012
20101

Applicants with the most clearances

Product code LSK
Applicants holding the most 510(k) clearances under product code LSK
ApplicantClearances
Hologic, Inc.4
Qiagen3
Abbott Molecular, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code