Acumedia Manufacturers, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 177
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0283-2019 | Class III | Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements | August 2, 2018 |
| Z-0284-2019 | Class III | Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective iso | August 2, 2018 |
| Z-2221-2017 | Class III | Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microo | September 25, 2016 |
| Z-2212-2017 | Class III | Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the | August 8, 2016 |
| Z-1093-2017 | Class II | Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes | April 22, 2016 |
| Z-2213-2017 | Class III | Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the di | March 23, 2016 |
| Z-2584-2017 | Class II | Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or | November 30, 2015 |
| Z-2214-2017 | Class III | Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standar | September 11, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K881551 | PHENOL RED BROTH BASE | April 18, 1988 |
| K881523 | DEXTROSE TRYPTONE BROTH | April 18, 1988 |
| K881562 | TRYPTOSE BLOOD AGAR BASE | April 18, 1988 |
| K881549 | MYCOLOGICAL AGAR W/LOW PH | April 18, 1988 |
| K881522 | DEXTROSE AGAR | April 18, 1988 |
| K881569 | STUARTS TRANSPORT MEDIUM | April 18, 1988 |
| K881577 | MODIFIED SELECTIVE STREPTOCOCCUS AGAR | April 18, 1988 |
| K881532 | BLOOD AGAR BASE W/LOW PH | April 18, 1988 |
| K881563 | TRYPTOSE PHOSPHATE BROTH | April 18, 1988 |
| K881486 | DNASE TEST AGAR | April 18, 1988 |
| K881524 | DERMATOPHYTE TEST MEDIUM | April 18, 1988 |
| K881543 | LETHEEN AGAR | April 18, 1988 |
| K881556 | TRICHOMONAS BROTH | April 18, 1988 |
| K881570 | SABOURAUD MALTOSE AGAR | April 18, 1988 |
| K881547 | MITIS SALIVARIUS AGAR | April 18, 1988 |
| K881541 | GELATIN | April 18, 1988 |
| K881537 | ANTIBIOTIC MEDIUM #19 | April 18, 1988 |
| K881553 | RUSSELL DOUBLE SUGAR AGAR | April 18, 1988 |
| K881554 | SKIM MILK DEHYDRATED | April 18, 1988 |
| K881555 | TINSDALE AGAR BASE | April 18, 1988 |