Data / Medical devices / United States / Hologic, Inc.
Hologic, Inc.: FDA-registered device maker in Londonderry, NH, United States, 1 PMA approval
Hologic, Inc. is registered with the FDA (registration 1221855) in Londonderry, NH, United States. It lists 5 device types. The FDA files 1 PMA approval under its listings, the newest dated May 20, 1996. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1221855
- Address
- 4 Navigator Rd, Londonderry, NH, United States, 03053
- Owner or operator
- HOLOGIC, INC. (9007676)
- Roles
- Manufacturer
- First device listed
- January 21, 2008
- Registered through
- 2026
- Brand names listed
- PreservCyt and CytoLyt, ThinPrep 2000 Slide Processor, ThinPrep 5000 Processor, ThinPrep Genesis Processor, ThinPrep Gynecological Filters, ThinPrep Gynecological Preservative (PreservCyt), ThinPrep Gynecological Slides, ThinPrep Imaging System Stain and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filters, Cell Collection, Tissue Processing | KET | 1 | Manufacturer | accessdata.fda.gov |
| Preservative, Cytological | LEA | 1 | Manufacturer | accessdata.fda.gov |
| Processor, Cervical Cytology Slide, Automated | MKQ | 3 | Manufacturer | accessdata.fda.gov |
| Reader, Cervical Cytology Slide, Automated | MNM | 3 | Manufacturer | accessdata.fda.gov |
| Stain, Papanicolau | HZJ | 1 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 20, 1996 | P950039 | THINPREP(R) PROCESSOR, MODEL TP 2000 | MKQ | 36 | August 27, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Filters, Cell Collection, Tissue Processing
- All makers of Preservative, Cytological
- All makers of Stain, Papanicolau
- All makers of Reader, Cervical Cytology Slide, Automated
- All makers of Processor, Cervical Cytology Slide, Automated
Updated August 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.