Data / Medical devices / United States / Remel Cleveland, A Division of Remel Inc.
Remel Cleveland, A Division of Remel Inc.: FDA-registered device maker in Oakwood Village, OH, United States, 8 510(k) clearances
Remel Cleveland, A Division of Remel Inc. is registered with the FDA (registration 1530126) in Oakwood Village, OH, United States. It lists 10 device types. The FDA files 8 510(k) clearances under its listings, the newest dated February 27, 2014. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1530126
- FEI number
- 1000515493
- Address
- 1 Thermo Fisher Way, Oakwood Village, OH, United States, 44146
- Owner or operator
- Thermo Fisher Scientific (2517925)
- Roles
- Specification developer
- First device listed
- September 25, 1998
- Registered through
- 2026
- Brand names listed
- 7102-44 VERSATREK REDOX 1, 80 ML W/STIR BAR, 7103-44 VERSATREK REDOX 2, 80ML, 7103-44M VERSATREK REDOX 2M 80ML, 7104-44 VERSATREK REDOX 80ML TWIN-PACK, 7106-44 VERSATREK REDOX 1, 40 ML W/STIR BAR, 7107-44 VERSATREK REDOX 2, EZ DRAW 40ML, 7110-44 VERSATREK REDOX 2M, EZ DRAW 40ML, 7111-42 VERSATREK MYCO BOTTLES and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | JTZ | 2 | Specification developer | accessdata.fda.gov |
| Gram Negative Identification Panel | LQM | 1 | Specification developer | accessdata.fda.gov |
| Gram Positive Identification Panel | LQL | 1 | Specification developer | accessdata.fda.gov |
| Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | LRG | 2 | Specification developer | accessdata.fda.gov |
| Manual Antimicrobial Susceptibility Test Systems | JWY | 2 | Specification developer | accessdata.fda.gov |
| Nephelometer, For Clinical Use | JQX | 1 | Specification developer | accessdata.fda.gov |
| Panels, Test, Susceptibility, Antimicrobial | LTT | 2 | Specification developer | accessdata.fda.gov |
| Reagent/Device, Inoculum Calibration | LIE | 2 | Specification developer | accessdata.fda.gov |
| Susceptibility Test Plate, Antifungal | NGZ | 2 | Specification developer | accessdata.fda.gov |
| System, Blood Culturing | MDB | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 27, 2014 | K133773 | SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| January 31, 2014 | K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | NGZ | Substantially Equivalent | Trek Diagnostic Systems | accessdata.fda.gov |
| November 16, 2011 | K112276 | VIZION | JWY | Substantially Equivalent | Trek Diagnostic Systems | accessdata.fda.gov |
| September 22, 2011 | K110583 | SENSITITRE OPTIREAD | LRG | Substantially Equivalent | Trek Diagnostic Systems, Ltd. | accessdata.fda.gov |
| August 18, 2011 | K111429 | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... | JWY | Substantially Equivalent | Trek Diagnostic Systems, Ltd. | accessdata.fda.gov |
| June 22, 2011 | K103456 | THE SENSITITRE AIM | LIE | Substantially Equivalent | Trek Diagnostic Systems | accessdata.fda.gov |
| August 22, 2003 | K032306 | VERSATREK | MDB | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| December 22, 1980 | K802957 | MUELLER HINTON BROTH | JTZ | Substantially Equivalent | Gibco Laboratories Life Technologies, 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 |
|---|---|---|---|---|---|---|
| January 4, 2019 | 84764 | Class II | Terminated | SWIN 2017 database, Model YSW4000 | Potential for out of range microbial results | accessdata.fda.gov |
| July 23, 2012 | 62757 | Class III | Terminated | VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System i | Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the VersaTREK instrument, the positive test result inadvertently reverted to a negative result in the instrument database. | accessdata.fda.gov |
| June 4, 2009 | 52813 | Not yet classified | Terminated | Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can | Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA. | accessdata.fda.gov |
| September 22, 2008 | 50129 | Not yet classified | Terminated | HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box | Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm. | accessdata.fda.gov |
| August 8, 2005 | 33135 | Not yet classified | Terminated | VersaTREK Myco AS. | Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results. | accessdata.fda.gov |
| March 4, 2005 | 31375 | Not yet classified | Terminated | Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case. | Blood culture bottles with an error in the bar code on the labels, were shipped. | accessdata.fda.gov |
Compare with other makers
- All makers of Susceptibility Test Plate, Antifungal
- All makers of Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- All makers of Manual Antimicrobial Susceptibility Test Systems
- All makers of Nephelometer, For Clinical Use
- All makers of Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- All makers of Panels, Test, Susceptibility, Antimicrobial
Updated February 27, 2014. 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.