APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)— 510(k) K132251
Substantially EquivalentHologic / Gen-Probe Incorporated
FDA 510(k) clearance K132251 for APTIMA COMBO 2 ASSAY (PANTHER SYSTEM), Substantially Equivalent on 2013-10-17. Applicant: Hologic / Gen-Probe Incorporated. Device class: 2.
Clearance details
- Applicant
- Hologic / Gen-Probe Incorporated
- Product code
- Code LSL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3390
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code LSL
view allRecalls naming K132251
K-number listed on FDA's recall record- Z-0595-2018 — Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.
- Z-0027-2018 — Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132251.
Data sourced from openFDA. This site is unofficial and independent of the FDA.