LEUKO-TEST
FDA 510(k) clearance K951101 · decided 1995-04-24
Clearance details
- K-number
- K951101
- Device name
- LEUKO-TEST
- Applicant
- Techlab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-10
- Decision date
- 1995-04-24
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- DEG
- Device class
- 1
- Regulation number
- 866.5570
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Blacksburg, VA, 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 |
|---|---|---|
| LEUKO EZ VUE (K071712) | Techlab Inc., Corporate Research Center | 2007-12-04 |
| IBD-SCAN (K042071) | Techlab, Inc. | 2004-10-20 |
| IBD-QUIK CHEK (K030704) | Techlab, Inc. | 2003-04-21 |
| IBD-CHEK (K011396) | Techlab, Inc. | 2001-06-18 |
| LACTOFERRIN MICROASSAY SYSTEM (K934473) | Touch Scientific, Inc. | 1993-12-03 |
| LACTOCARD (K931901) | Touch Scientific, Inc. | 1993-07-06 |
| LACTOPLATE (K852737) | Mackeen Consultants, Ltd. | 1985-10-25 |
Recalls involving this device
No recalls on record reference this clearance.