510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092704Substantially Equivalent

Abbott Realtime Ct/ng and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03

Abbott Molecular, Inc., Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092704 is the FDA 510(k) clearance record for ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03, a class I device, cleared for Abbott Molecular, Inc. on under FDA product code LSK (Dna-Reagents, Chlamydia). FDA records list 19 510(k) clearances for Abbott Molecular, Inc., from to . As of , FDA records show one recall naming K092704.

Clearance record

Decision date
Received
(267 days to decision)
Product code
LSK Dna-Reagents, Chlamydia
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Applicant
Abbott Molecular, Inc. 1300 E Touhy Ave., Des Plaines IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LSK

Trailing 12 months

FDA records hold no clearances under product code LSK in the trailing twelve months.

FDA records show no clearances under product code LSK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LSK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260