510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920378Substantially Equivalent

Pace 2 System for Chlamydia Trachomatis

Hologic, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920378 is the FDA 510(k) clearance record for PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS, a class I device, cleared for Gen-Probe, Inc. on under FDA product code LSK (Dna-Reagents, Chlamydia). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K920378.

Clearance record

Decision date
Received
(91 days to decision)
Product code
LSK Dna-Reagents, Chlamydia
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Applicant
Gen-Probe, Inc. 9880 Campus Pt. Dr., San Diego CA
510(k) summary
Summary
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