Data / Medical devices / United States / Neogen Culture Media
Neogen Culture Media: FDA-registered device maker in Lansing, MI, United States, 1 510(k) clearance
Neogen Culture Media is registered with the FDA (registration 1120041) in Lansing, MI, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 1981. 8 recall events name it as the recalling firm. 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
- 1120041
- Address
- 740 East Shiawassee, Lansing, MI, United States, 48912
- Owner or operator
- NEOGEN CORP. (9028759)
- Roles
- Manufacturer
- First device listed
- November 20, 1992
- Registered through
- 2026
- Brand names listed
- Cystine Lactose Electrolyte Deficient (CLED) Agar, Mueller Hinton Agar
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | JTZ | 2 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Differential | JSH | 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 |
|---|---|---|---|---|---|---|
| April 29, 1981 | K811049 | MUELLER HINTON AGAR | JTZ | Substantially Equivalent | Acumedia Manufacturers, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 2, 2018 | 81115 | Class III | Terminated | Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environm | Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021. | accessdata.fda.gov |
| August 2, 2018 | 81107 | Class III | Terminated | Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions i | The product is labeled with an incorrect expiration date. | accessdata.fda.gov |
| September 25, 2016 | 77276 | Class III | Terminated | Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production | Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C. | accessdata.fda.gov |
| August 8, 2016 | 77281 | Class III | Terminated | Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds | Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C. | accessdata.fda.gov |
| April 22, 2016 | 76053 | Class II | Terminated | Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes | light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts. | accessdata.fda.gov |
| March 23, 2016 | 77275 | Class III | Terminated | Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-ne | Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018. | accessdata.fda.gov |
| November 30, 2015 | 77283 | Class II | Terminated | Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmen | Contamination of product with possible Bacillus spp | accessdata.fda.gov |
| September 11, 2015 | 77272 | Class III | Terminated | Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media contai | Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019. | accessdata.fda.gov |
Compare with other makers
- All makers of Culture Media, Non-Selective And Differential
- All makers of Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Updated April 29, 1981. 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.