Data / Medical devices / United States / Lee Laboratories, Inc.
Lee Laboratories, Inc.: FDA-registered device maker in Grayson, GA, United States, 2 510(k) clearances
Lee Laboratories, Inc. is registered with the FDA (registration 1025402) in Grayson, GA, United States. It lists 13 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 1, 1998. 3 recall events name it as the recalling firm. Registered through 2027. 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
- 1025402
- Address
- 1475 Athens Hwy., Grayson, GA, United States, 30017
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Manufacturer
- First device listed
- December 27, 1992
- Registered through
- 2027
- Brand names listed
- 241115 - BD Francisella tularensis Antigen, 241116 - BD Francisella tularensis Antisera, 333947 - BD CD117 PerCP-Cy5.5, 333948 - BD CD14 APC-Cy7, 333949 - BD CD33 PE-Cy7, 335804 - BD CD2 PE-Cy7, 335805 - BD CD8 PE-Cy7, 335806 - BD CD16 (B73.1) PE-Cy7 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, B. Pertussis | GOX | 1 | Manufacturer | accessdata.fda.gov |
| Antigens, All Groups, Salmonella Spp. | GRL | 2 | Manufacturer | accessdata.fda.gov |
| Antisera, Agglutinating, B. Parapertussis | GOW | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, Agglutinating, B. Pertussis, All | GOY | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, All Groups, Salmonella Spp. | GRM | 2 | Manufacturer | accessdata.fda.gov |
| Antisera, All Types, Escherichia Coli | GNA | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, All Types, H. Influenza | GRP | 2 | Manufacturer | accessdata.fda.gov |
| Antisera, All Types, Listeria Monocytogenes | GSH | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, All Types, Shigella Spp. | GNB | 2 | Manufacturer | accessdata.fda.gov |
| Antiserum, Vibrio Cholerae, All Varieties | GSQ | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Coagulase, Human, Horse And Rabbit | JTL | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| System, Blood Culturing | MDB | 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 |
|---|---|---|---|---|---|---|
| May 1, 1998 | K974883 | BACTEC MGIT 960 SYSTEM | MDB | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 21, 1996 | K954932 | BBL MGIT PRODUCTS | MDB | Substantially Equivalent | Becton Dickinson Diagnostic Instrument Systems | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 6, 2007 | 46750 | Not yet classified | Terminated | BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton Dickinson and Company, Sparks, MD 21152. The product is packaged | Exhibits cross reactivity with Neisseria meningitides Group W135. | accessdata.fda.gov |
| August 8, 2007 | 46759 | Not yet classified | Terminated | DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic. | Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism. | accessdata.fda.gov |
| October 20, 2004 | 30443 | Not yet classified | Terminated | BD, Brucella melitensis Antigen | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | accessdata.fda.gov |
Compare with other makers
- All makers of Reagents, Specific, Analyte
- All makers of Antisera, Agglutinating, B. Pertussis, All
- All makers of Antisera, All Types, Listeria Monocytogenes
- All makers of Antisera, All Groups, Salmonella Spp.
- All makers of Antisera, All Types, H. Influenza
- All makers of Antiserum, Vibrio Cholerae, All Varieties
Updated August 8, 2008. 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.