IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
FDA 510(k) clearance K012312 · decided 2001-08-20
Clearance details
- K-number
- K012312
- Device name
- IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-23
- Decision date
- 2001-08-20
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- KLB
- Device class
- 2
- Regulation number
- 862.3900
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Los Angeles, CA, 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 |
|---|---|---|
| ONLINE TDM TOBRAMYCIN (K060853) | Roche Diagnostics Corp. | 2006-06-09 |
| EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS (K003341) | Syva Co., Dade Behring, Inc. | 2001-01-22 |
| DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD (K904304) | E.I. Dupont DE Nemours & Co., Inc. | 1990-10-26 |
| IL TOBRAMYCIN ASSAY (K903192) | Instrumentation Laboratory CO | 1990-08-22 |
| TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD (K893913) | Technicon Instruments Corp. | 1989-08-21 |
| EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY (K882294) | Syva Co. | 1988-07-01 |
| EMIT TOBRAMYCIN ASSAY (K874223) | Syva Co. | 1987-11-13 |
| IN-VITRO TEST DETERMINATION OF TOBRAMYCIN (K854184) | Clinical Data, Inc. | 1985-12-04 |
| ACA TOBRAMY-CIN ANALYTICAL TEST PACK (K852671) | E.I. Dupont DE Nemours & Co., Inc. | 1985-07-22 |
| TOBRAMYCIN REAGENT (K832763) | Biosan Laboratories, Inc. | 1984-03-23 |
| TOBRAMYCIN ANALYTICAL TEST PACK-ACA (K832985) | E.I. Dupont DE Nemours & Co., Inc. | 1983-10-27 |
| COAT-A-COUNT TOBRAMYCIN RIA KIT (K822858) | Diagnostic Products Corp. | 1982-10-18 |
Recalls involving this device
No recalls on record reference this clearance.