Panels › Microbiology › Product code LJG · Class 1
Quality Control Slides
Regulation 866.2660
0510(k)s in 12 months (27 all time)
0recalls in 12 months (5 all time)
1recalls that name a 510(k)
Top companies in LJG
| Company | 510(k)s | Recalls |
|---|---|---|
| Sigma Diagnostics, Inc. | 7 | 0 |
| Scientific Device Laboratory, Inc. | 6 | 0 |
| Val Tech Diagnostics, Inc. | 6 | 0 |
| Alpha-Tec Systems, Inc. | 4 | 0 |
| Microbiologics Inc | 0 | 2 |
| Opgen Inc | 0 | 2 |
| Bion Ent., Ltd. | 1 | 0 |
| Lab Ability, Inc. | 1 | 0 |
| Medastat Scientific Corp. | 1 | 0 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2019 | Opgen Inc CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic
The CS011 GNR Traffic Light Control Slide provides a positive and Terminated |
LJG | None listed |
| May 14, 2018 | Opgen Inc AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012
Control slides included as a component of the QFFIXBC1-25. The slides will provide Terminated |
LJG | None listed |
| Mar 28, 2013 | Microbiologics Inc Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides).
Slide preparations serving as quality control challenges to demonstrate satisfactory performance of s Terminated |
LJG | None listed |
| Jul 3, 2012 | Microbiologics Inc Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. Terminated |
LJG | None listed |
| Dec 25, 2003 | Remel, Inc. Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS. Terminated |
LJG | K890718 |
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