QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
FDA 510(k) clearance K123593 · decided 2013-04-17
Clearance details
- K-number
- K123593
- Device name
- QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-21
- Decision date
- 2013-04-17
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- LKP
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| VARELISA SM ANTIBODIES (K000312) | Pharmacia & Upjohn Co. | 2000-03-17 |
| AUTOSTAT II ANTI-SM ELISA (K990625) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 (K984479) | Bio-Rad | 1998-12-22 |
| THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO (K983420) | Zeus Scientific, Inc. | 1998-11-18 |
Recalls involving this device
No recalls on record reference this clearance.