Company ยท US
Acumedia Manufacturers, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1988. Name variants (Inc, Corp, punctuation) are merged.
177510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | 45 |
| JSI | Culture Media, Selective And Differential | 43 |
| JSJ | Culture Media, Selective And Non-Differential | 31 |
| JSH | Culture Media, Non-Selective And Differential | 21 |
| JSK | Supplement, Culture Media | 11 |
| JSA | Culture Media, Antibiotic Assay | 8 |
| JSC | Culture Media, General Nutrient Broth | 6 |
| JSM | Culture Media, Non-Propagating Transport | 3 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 2 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 |
| LKA | Culture Media, Antimicrobial Susceptibility Test | 2 |
| JAK | System, X-Ray, Tomography, Computed | 1 |
| JKS | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | 1 |
| JSD | Culture Media, Selective Broth | 1 |
| JSE | Culture Media, Multiple Biochemical Test | 1 |
| JSN | Culture Media, Propagating Transport | 1 |
| JSQ | Chromatography For Bacterial Identification | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 18, 1988 | K881579 | AMIES TRANSPORT MEDIUM W/O CHARCOAL Acumedia Manufacturers, Inc. | JSN |
| Apr 18, 1988 | K881578 | STREPTOSEL Acumedia Manufacturers, Inc. | JSJ |
| Apr 18, 1988 | K881577 | MODIFIED SELECTIVE STREPTOCOCCUS AGAR Acumedia Manufacturers, Inc. | JSI |
| Apr 18, 1988 | K881576 | SELENITE BROTH Acumedia Manufacturers, Inc. | JSI |
| Apr 18, 1988 | K881575 | SELECTIVE STREPTOCOCCUS AGAR Acumedia Manufacturers, Inc. | JSI |
| Apr 18, 1988 | K881574 | W-L DIFFERENTIAL MEDIUM Acumedia Manufacturers, Inc. | JSJ |
| Apr 18, 1988 | K881573 | PHYTONE YEAST EXTRACT AGAR Acumedia Manufacturers, Inc. | JSJ |
| Apr 18, 1988 | K881572 | XL AGAR BASE Acumedia Manufacturers, Inc. | JSI |
| Apr 18, 1988 | K881571 | YM BROTH Acumedia Manufacturers, Inc. | JSJ |
| Apr 18, 1988 | K881570 | SABOURAUD MALTOSE AGAR Acumedia Manufacturers, Inc. | JSJ |
| Apr 18, 1988 | K881569 | STUARTS TRANSPORT MEDIUM Acumedia Manufacturers, Inc. | JSM |
| Apr 18, 1988 | K881568 | WILKENS CHALGREN BROTH Acumedia Manufacturers, Inc. | JSO |
| Apr 18, 1988 | K881567 | WILKENS CHALGREN AGAR Acumedia Manufacturers, Inc. | JSO |
| Apr 18, 1988 | K881566 | HEMOGLOBIN POWDER Acumedia Manufacturers, Inc. | JSK |
| Apr 18, 1988 | K881565 | INHIBITORY MOLD AGAR Acumedia Manufacturers, Inc. | JSJ |
| Apr 18, 1988 | K881564 | TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881563 | TRYPTOSE PHOSPHATE BROTH Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881562 | TRYPTOSE BLOOD AGAR BASE Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881561 | TERGITOL 7 BROTH Acumedia Manufacturers, Inc. | JSJ |
| Apr 18, 1988 | K881560 | UREA BROTH Acumedia Manufacturers, Inc. | JSH |
| Apr 18, 1988 | K881559 | UREA AGAR BASE Acumedia Manufacturers, Inc. | JSH |
| Apr 18, 1988 | K881558 | TRYPTOSE AGAR Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881557 | TRYPTONE Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881556 | TRICHOMONAS BROTH Acumedia Manufacturers, Inc. | JSI |
| Apr 18, 1988 | K881555 | TINSDALE AGAR BASE Acumedia Manufacturers, Inc. | JSI |
| Apr 18, 1988 | K881554 | SKIM MILK DEHYDRATED Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881553 | RUSSELL DOUBLE SUGAR AGAR Acumedia Manufacturers, Inc. | JSH |
| Apr 18, 1988 | K881552 | PROTEOSE NO. 3 AGAR Acumedia Manufacturers, Inc. | JTY |
| Apr 18, 1988 | K881551 | PHENOL RED BROTH BASE Acumedia Manufacturers, Inc. | JSH |
| Apr 18, 1988 | K881550 | OF BASAL MEDIUM Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881549 | MYCOLOGICAL AGAR W/LOW PH Acumedia Manufacturers, Inc. | JSJ |
| Apr 18, 1988 | K881548 | MPH AGAR Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881547 | MITIS SALIVARIUS AGAR Acumedia Manufacturers, Inc. | JSJ |
| Apr 18, 1988 | K881546 | MALT EXTRACT AGAR Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881545 | MALT EXTRACT Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881544 | LITTMAN AGAR Acumedia Manufacturers, Inc. | JSJ |
| Apr 18, 1988 | K881543 | LETHEEN AGAR Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881542 | HEART INFUSION AGAR Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881541 | GELATIN Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881540 | FLO AGAR Acumedia Manufacturers, Inc. | JSH |
| Apr 18, 1988 | K881539 | AMIES TRANSPORT MEDIUM Acumedia Manufacturers, Inc. | JSM |
| Apr 18, 1988 | K881538 | ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR Acumedia Manufacturers, Inc. | JSA |
| Apr 18, 1988 | K881537 | ANTIBIOTIC MEDIUM #19 Acumedia Manufacturers, Inc. | JSA |
| Apr 18, 1988 | K881536 | ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR Acumedia Manufacturers, Inc. | JSA |
| Apr 18, 1988 | K881535 | ANTIBIOTIC MEDIUM #6 Acumedia Manufacturers, Inc. | JSA |
| Apr 18, 1988 | K881534 | ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR Acumedia Manufacturers, Inc. | JSA |
| Apr 18, 1988 | K881533 | BLOOD AGAR BASE NO. 2 Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881532 | BLOOD AGAR BASE W/LOW PH Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881531 | BLOOD AGAR BASE, IMPROVED Acumedia Manufacturers, Inc. | JSG |
| Apr 18, 1988 | K881530 | BRILLIANT GREEN AGAR W/SULFADIAZINE Acumedia Manufacturers, Inc. | JSJ |
Newest 50 of 177.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2018 | Acumedia Manufacturers, Inc. 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 fro Terminated |
JSI | None listed |
| Aug 2, 2018 | Acumedia Manufacturers, Inc. 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 Terminated |
JSJ | None listed |
| Jun 1, 2017 | Acumedia Manufacturers, Inc. 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 Terminated |
JSG | None listed |
| Jun 1, 2017 | Acumedia Manufacturers, Inc. 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 Terminated |
JSG | None listed |
| Jun 1, 2017 | Acumedia Manufacturers, Inc. 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 me Terminated |
JSK | None listed |
| Sep 25, 2016 | Acumedia Manufacturers, Inc. Urea Base Agar, Acumedia PN 7226
Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production Terminated |
JSI | None listed |
| Apr 22, 2016 | Acumedia Manufacturers, Inc. Tryptic Soy Agar, Acumedia PN 7100
500g, 2Kg, 10Kg, and 50Kg sizes Terminated |
JSG | None listed |
| Nov 30, 2015 | Acumedia Manufacturers, Inc. 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 foo Terminated |
JSI | None listed |