Metachromatic Granule Stain Control
FDA 510(k) K840516 · Scientific Device Laboratory, Inc.
510(k) numberK840516
Submission
- Device name
- Metachromatic Granule Stain Control
- Applicant
- Scientific Device Laboratory, Inc.
Mchenry, IL, US - Received
- February 6, 1984
- Decision date
- March 9, 1984
- 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 |
| K883567 | Histo-Check Legionella Control SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
More from Val Tech Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935316 | Parasafe(R) FixativeLKS · Traditional | 02/17/1994SE |
| K924893 | Microsporidium Control SlideLJG · Traditional | 01/15/1993SE |
| K911059 | Turbidometric StandardLIE · Traditional | 06/10/1991SE |
| K895848 | Pressure Steam SterilizersFLE · Traditional | 12/11/1989SE |
| K890718 | Gram Stain Control SlideLJG · Traditional | 03/16/1989SE |
| K890670 | Cryptosporidium Control SlideLJG · Traditional | 03/16/1989SE |
| K884069 | Snap N' Stain Iodine StainJTS · Traditional | 10/25/1988SE |
| K884011 | Snap N' Stain Iron StainGGH · Traditional | 10/06/1988SE |
| K883052 | Metheno-Stain KitJTS · Traditional | 08/30/1988SE |
| K881598 | SDL Trichrome StainJTS · Traditional | 05/04/1988SE |
Questions and answers
When was Metachromatic Granule Stain Control cleared by the FDA?
Metachromatic Granule Stain Control (K840516) received a 510(k) decision of Substantially Equivalent on March 9, 1984, 32 days after the submission was received.
What is the product code of K840516?
The FDA product code is LJG – Quality Control Slides, a Class I (low risk) device regulated under 21 CFR 866.2660.