GRAM STAIN CONTROL SLIDE
FDA 510(k) clearance K890718 · decided 1989-03-16
Clearance details
- K-number
- K890718
- Device name
- GRAM STAIN CONTROL SLIDE
- Applicant
- Scientific Device Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-13
- Decision date
- 1989-03-16
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- LJG
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Glenview, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MICROSPORIDIUM CONTROL SET (K943228) | Meridian Diagnostics, Inc. | 1994-10-27 |
| MICROSPORIDIUM CONTROL SLIDE (K924893) | Scientific Device Laboratory, Inc. | 1993-01-15 |
| CRYPTOSPORIDIUM CONTROL SLIDE (K890670) | Scientific Device Laboratory, Inc. | 1989-03-16 |
| BION DIRECT IDENTIFICATION CONTROL SLIDE (K890616) | Bion Ent., Ltd. | 1989-02-17 |
| HISTO-CHECK FUNGAL CONTROL SLIDES (K883570) | Val Tech Diagnostics, Inc. | 1988-10-06 |
| HISTO-CHECK LEGIONELLA CONTROL SLIDES (K883567) | Val Tech Diagnostics, Inc. | 1988-10-06 |
| HISTO-CHECK GRAM NEGATIVE SLIDES (K883569) | Val Tech Diagnostics, Inc. | 1988-10-06 |
| HISTO-CHECK PARASITIC CONTROL SLIDES (K883571) | Val Tech Diagnostics, Inc. | 1988-10-06 |
| HISTO-CHECK ACID FAST SLIDES (K883568) | Val Tech Diagnostics, Inc. | 1988-10-06 |
| HISTO-CHECK SLIDES (K883208) | Val Tech Diagnostics, Inc. | 1988-08-25 |
| ACID FAST BACILLI HISTOLOGY CONTROL SLIDES (K881106) | Sigma Diagnostics, Inc. | 1988-04-21 |
| SPIROCHETES HISTOLOGY CONTROL SLIDES (K881109) | Sigma Diagnostics, Inc. | 1988-04-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm o recall (Z-0273-04) | Remel, Inc. | 2003-12-25 |