Histo-Check Legionella Control Slides
FDA 510(k) K883567 · Val Tech Diagnostics, Inc.
510(k) numberK883567
Submission
- Device name
- Histo-Check Legionella Control Slides
- Applicant
- Val Tech Diagnostics, Inc.
Pittsburgh, PA, US - Received
- August 22, 1988
- Decision date
- October 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJG – Quality Control Slides
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943228 | Microsporidium Control SetLJG · Traditional | Meridian Diagnostics, Inc. | 10/27/1994SE |
| K924893 | Microsporidium Control SlideLJG · Traditional | Scientific Device Laboratory, Inc. | 01/15/1993SE |
| K890718 | Gram Stain Control SlideLJG · Traditional | Scientific Device Laboratory, Inc. | 03/16/1989SE |
| K890670 | Cryptosporidium Control SlideLJG · Traditional | Scientific Device Laboratory, Inc. | 03/16/1989SE |
| K890616 | Bion Direct Identification Control SlideLJG · Traditional | Bion Ent., Ltd. | 02/17/1989SE |
| K883571 | Histo-Check Parasitic Control SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883570 | Histo-Check Fungal Control SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883569 | Histo-Check Gram Negative SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883568 | Histo-Check Acid Fast SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883208 | Histo-Check SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 08/25/1988SE |
More from Val Tech Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883571 | Histo-Check Parasitic Control SlidesLJG · Traditional | 10/06/1988SE |
| K883570 | Histo-Check Fungal Control SlidesLJG · Traditional | 10/06/1988SE |
| K883569 | Histo-Check Gram Negative SlidesLJG · Traditional | 10/06/1988SE |
| K883568 | Histo-Check Acid Fast SlidesLJG · Traditional | 10/06/1988SE |
| K883684 | Herpes Virus Control SlidesGQN · Traditional | 09/28/1988SE |
| K883232 | Histone Reactive AnaLLL · Traditional | 09/07/1988SE |
| K883208 | Histo-Check SlidesLJG · Traditional | 08/25/1988SE |
| K871395 | Dual Substrate AnaDHN · Traditional | 04/20/1987SE |
| K864668 | Ana Test KitLKJ · Traditional | 03/12/1987SE |
| K870732 | Rat Liver Nuclei Test SystemDHN · Traditional | 03/10/1987SE |
Questions and answers
When was Histo-Check Legionella Control Slides cleared by the FDA?
Histo-Check Legionella Control Slides (K883567) received a 510(k) decision of Substantially Equivalent on October 6, 1988, 45 days after the submission was received.
What is the product code of K883567?
The FDA product code is LJG – Quality Control Slides, a Class I (low risk) device regulated under 21 CFR 866.2660.