Whatman, Inc.
Ann Arbor, MI, US
Whatman, Inc. appears in FDA device records in Ann Arbor, MI. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Whatman, Inc. 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.
- GE Healthcare Biosciencesenforcement report, recall
510(k) clearance history
FDA records hold 1 510(k) clearance for Whatman, Inc. in 2000.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0388-2019 | DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time. | Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant. | Class II | Terminated | |
| Z-2384-2010 | Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790 | Neonate newborn screening card demographic and filter portion may be detached | Terminated | ||
| Z-1005-2010 | Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ. The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood. | '903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results | Terminated | ||
| Z-1871-2009 | Whatman Body Fluid Collection Paper 903 The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood. | The two portions of the card are coming apart prematurely. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain