PROTOZOA STAIN CONTROL
FDA 510(k) clearance K840517 · decided 1984-03-09
Clearance details
- K-number
- K840517
- Device name
- PROTOZOA STAIN CONTROL
- Applicant
- Scientific Device Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-06
- Decision date
- 1984-03-09
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- LJG
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, 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 |
| GRAM STAIN CONTROL SLIDE (K890718) | Scientific Device Laboratory, Inc. | 1989-03-16 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.