TOBRAMYCIN FLEX REAGENT CARTRIDGE
FDA 510(k) clearance K962818 · decided 1996-09-13
Clearance details
- K-number
- K962818
- Device name
- TOBRAMYCIN FLEX REAGENT CARTRIDGE
- Applicant
- Dade Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-19
- Decision date
- 1996-09-13
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LCR
- Device class
- 2
- Regulation number
- 862.3900
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Newark, DE, 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 |
|---|---|---|
| QMS TOBRAMYCIN (K060998) | Seradyn, Inc. | 2006-07-21 |
| ACS TOBRAMYCIN (K974029) | Chiron Diagnostics Corp. | 1998-02-12 |
| BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT (K952568) | Beckman Instruments, Inc. | 1995-08-08 |
| OPUS(R) TOBRAMYCIN (K911940) | Pb Diagnostic Systems, Inc. | 1991-07-01 |
| VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 (K911613) | Exmoor Plastics , Ltd. | 1991-06-28 |
| INTRAOCULAR PRESSURE REDUCER (K854873) | Mira, Inc. | 1986-02-04 |
| DU PONT TOBRAMYCIN ASSAY REAGENTS (K850058) | E.I. Dupont DE Nemours & Co., Inc. | 1985-01-18 |
| IMMPULSE TOBRAMYCIN ASSAY REAGENTS (K840847) | Paragon Diagnostics, Inc. | 1984-04-04 |
| STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM (K832408) | American Dade | 1983-08-26 |
| NEEDLE HOLDERS (K822197) | Kelleher Corp. | 1982-08-16 |
| VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA (K821542) | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 |
| ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY (K820130) | Syva Co. | 1982-02-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS (P870049/S032) | Dade Intl., Inc. | 2001-11-30 |
| MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S031) | Dade Intl., Inc. | 2001-11-09 |
| MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S030) | Dade Intl., Inc. | 2000-06-05 |
| MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S029) | Dade Intl., Inc. | 1999-06-24 |
| MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S028) | Dade Intl., Inc. | 1999-01-25 |
| MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S027) | Dade Intl., Inc. | 1998-06-30 |
| MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS (P870049/S025) | Dade Intl., Inc. | 1996-05-03 |
| MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S024) | Dade Intl., Inc. | 1996-03-12 |