Data / Medical devices / United States / Immucor, Inc.
Immucor, Inc.: FDA-registered device maker in Norcross, GA, United States, 7 510(k) clearances
Immucor, Inc. is registered with the FDA (registration 1034569) in Norcross, GA, United States. It lists 15 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 22, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1034569
- Address
- 3130 Gateway DR., Norcross, GA, United States, 30071
- Owner or operator
- IMMUCOR, INC. (1034569)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 6, 1977
- Registered through
- 2026
- Brand names listed
- Anti-A1 Lectin, Anti-H Lectin, Blood Bank Droppers, Bovine Albumin 22%, Capture Positive Control Cell (Component of Capture-R Ready-Screen (3) and Ready-ID), Capture-CMV, Capture-P Ready Screen Test System, Capture-P Test System and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| March 22, 2021 | K203612 | Capture-CMV | LJO | Substantially Equivalent | Immucor, Inc. | accessdata.fda.gov |
| March 20, 1991 | K910003 | CYTOMEGALOVIRUS ANTIBODY SCREEN | LJO | Substantially Equivalent | Immucor, Inc. | accessdata.fda.gov |
| March 4, 1982 | K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | KSK | Substantially Equivalent | Gamma Biologicals, Inc. | accessdata.fda.gov |
| July 21, 1981 | K810803 | FREEZE DRIED PAPAIN | KSK | Substantially Equivalent | Biological Corp. of America | accessdata.fda.gov |
| November 12, 1980 | K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | KSX | Substantially Equivalent | Gamma Biologicals, Inc. | accessdata.fda.gov |
| November 12, 1980 | K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | KSX | Substantially Equivalent | Gamma Biologicals, Inc. | accessdata.fda.gov |
| June 15, 1979 | K790973 | LO-ION | KSG | Substantially Equivalent | Gamma Biologicals, Inc. | accessdata.fda.gov |
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Updated March 22, 2021. 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.