510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Promega Corporation

Madison, WI, US

Promega Corporation appears in FDA device records in Madison, WI. FDA records list one 510(k) clearance, one PMA record and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
1
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Promega Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Promega Corpoprationrecall

510(k) clearance history

FDA records hold 1 510(k) clearance for Promega Corporation in 2021.

Clearances by year, as a table
510(k) clearance decisions for Promega Corporation, by decision year
YearClearances
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200129OncoMate MSI Dx Analysis SystemPZJSubstantially Equivalent

Registered establishments

FDA registered establishments for Promega Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21345673002622561Promega Corporation2800 Woods Hollow Road, Madison, WI 53711 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0483-2009RNAgents Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use. Promega Corporation, Madison, WI. USA. Bottle Label: Phenol: Chloroform: Isoamyl Alcohol (Cat.# Z5112). Part Two of Two of Z5110. Size 100ml. For laboratory Use. A component of the RNAgents Total RNA Isolation System. The RNAgents Total RNA Isolation System provides a scalable method for RNA isolation from 6 grams of tissue or 6 x 10 (eighth power) cultured cells. The system reduces the level of chromosomal DNA, a major advantage when the downstream application of amplification and analysis of RNA transcripts is desired. Isolated RNA can be resuspended in any volume, making the system ideal for microarrays.Promega Corporation received reports of leaking bottles of Phenol:Chloroform:Isoamyl Alcohol (Part # Z5112), a component of the RNAgents Total RNA Isolation System (Catalog # Z5110). Promega product Z5112 is a mixture of phenol, chloroform and isoamyl alcohol. If phenol contacts skin, it can cause burns and poisoning. The fumes of this product are also harmful.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain