SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
FDA 510(k) clearance K993981 · decided 2000-02-01
Clearance details
- K-number
- K993981
- Device name
- SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-24
- Decision date
- 2000-02-01
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- JXN
- Device class
- 2
- Regulation number
- 862.3700
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Jose, 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 |
|---|
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| PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL (K111363) | Medica Corp. | 2011-12-06 |
| ONLINE DAT PROPOXYPHENE PLUS (K043303) | Roche Diagnostics Corp. | 2005-03-11 |
| ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE (K040445) | ACON Laboratories, Inc. | 2004-05-19 |
| 'RAPID ONE' - PROPOXYPHENE TEST (K030835) | American Bio Medica Corp. | 2003-05-22 |
| PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) (K023795) | Lin-Zhi International, Inc. | 2003-01-21 |
| INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST (K022915) | Alfa Scientific Designs, Inc. | 2002-11-29 |
| VERDICT-II PROPOXYPHENE (K020787) | Medtox Diagnostics, Inc. | 2002-05-02 |
| PROPOXYPHENE (K013100) | Abbott Laboratories | 2002-03-20 |
| MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 (K011163) | Syva Co., Dade Behring, Inc. | 2001-05-10 |
| MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (K983700) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
Recalls involving this device
No recalls on record reference this clearance.