Data / Medical devices / United States / LGC Clinical Diagnostics, Inc.
LGC Clinical Diagnostics, Inc.: FDA-registered device maker in Cumberland Foreside, ME, United States, 11 510(k) clearances
LGC Clinical Diagnostics, Inc. is registered with the FDA (registration 1226774) in Cumberland Foreside, ME, United States. It lists 5 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 14, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1226774
- FEI number
- 3003407015
- Address
- 221 US Route 1, Cumberland Foreside, ME, United States, 04110
- Owner or operator
- LGC Clinical Diagnostics, Inc. (9041170)
- Roles
- Manufacturer
- First device listed
- August 18, 2015
- Registered through
- 2026
- Brand names listed
- ACCURUN 2 Series 5600, ACCURUN 3 Multi Marker Positive Control, ACCURUN 4 Multi-Marker Positive Control, ACCURUN 5 Multi Marker Positive Control, ACCURUN 51 S2700, ACCURUN 6 Multi Marker Positive Control, ACCURUN 810 S2700, ACCURUN Anti-SARS-CoV-2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | 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 |
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 |
|---|---|---|---|---|---|---|
| June 14, 2013 | K123127 | VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 | JJX | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
| January 27, 2012 | K113524 | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT | JJX | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
| June 25, 2009 | K091225 | VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET | JJY | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
| April 16, 2009 | K090475 | VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 | JJY | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
| March 23, 2009 | K083891 | VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 | JJY | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
| September 14, 2007 | K072246 | VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 | JJY | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
| January 13, 2006 | K053247 | VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET | JJY | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
| March 25, 2005 | K050504 | VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS | JJY | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
| October 15, 2004 | K041975 | VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 | JJY | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
| August 20, 2001 | K012120 | VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 | JJY | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
| August 20, 2001 | K012117 | VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 | JJY | Substantially Equivalent | Maine Standards Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Multi-Analyte Controls Unassayed
- All makers of Urinalysis Controls (Assayed And Unassayed)
Updated June 14, 2013. 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.