Data / Medical devices / United States / LGC Clinical Diagnostics, Inc.
LGC Clinical Diagnostics, Inc.: FDA-registered device maker in Milford, MA, United States, 5 510(k) clearances
LGC Clinical Diagnostics, Inc. is registered with the FDA (registration 3007088335) in Milford, MA, United States. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 11, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007088335
- FEI number
- 1220394
- Address
- 37 Birch St, Milford, MA, United States, 01757
- Owner or operator
- LGC Clinical Diagnostics, Inc. (9041170)
- Roles
- Manufacturer
- First device listed
- December 28, 2006
- Registered through
- 2026
- Brand names listed
- ACCURUN 1 Multi-Marker Positive Control Series 2400, ACCURUN 1 Multi-Marker Positive Control Series 2500, ACCURUN 1 Multi-Marker Positive Control Series 2700, ACCURUN 1 Multi-Marker Positive Control Series 4000, ACCURUN 1 Multi-Marker Positive Control Series 4400, ACCURUN 1 Multi-Marker Positive Control Series 5100, ACCURUN 1 Multi-Marker Positive Control Series 5600, ACCURUN 1 Multi-Marker Positive Control Series 8100 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antibody Igm,If, Cytomegalovirus Virus | LKQ | 2 | Manufacturer | accessdata.fda.gov |
| Antisera, If, Toxoplasma Gondii | LJK | 2 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Quality Control For Blood Banking Reagents | KSF | 2 | Manufacturer | accessdata.fda.gov |
| Kit, Serological, Positive Control | MJX | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Test (Donors), For Bloodborne Pathogen | MYZ | 2 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Urinalysis Controls (Assayed And Unassayed) | JJW | 1 | Manufacturer | accessdata.fda.gov |
| Whole Blood Plasma, Antigen, Antiserum, Control | DGQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 11, 1997 | K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | LJK | Substantially Equivalent | Boston Biomedica, Inc. | accessdata.fda.gov |
| October 8, 1997 | K972986 | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL | MJX | Substantially Equivalent | Boston Biomedica, Inc. | accessdata.fda.gov |
| August 22, 1997 | K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL | LKQ | Substantially Equivalent | Boston Biomedica, Inc. | accessdata.fda.gov |
| August 12, 1997 | K972048 | ACCURUN 117 HBEAG POSITIVE CONTROL | JJY | Substantially Equivalent | Boston Biomedica, Inc. | accessdata.fda.gov |
| August 7, 1997 | K972307 | ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL | JJY | Substantially Equivalent | Boston Biomedica, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Urinalysis Controls (Assayed And Unassayed)
- All makers of Kit, Quality Control For Blood Banking Reagents
- All makers of Multi-Analyte Controls Unassayed
- All makers of Kit, Serological, Positive Control
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
Updated December 11, 1997. 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.