PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
FDA 510(k) clearance K943313 · decided 1994-10-27
Clearance details
- K-number
- K943313
- Device name
- PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-11
- Decision date
- 1994-10-27
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- LGR
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- St. Louis, MO, 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 |
|---|---|---|
| ACS PHENYTOIN ASSAY (K955873) | Ciba Corning Diagnostics Corp. | 1996-03-11 |
| INNOFLUOR PHENYTOIN ASSAY SYSTEM (K955562) | Oxis Intl., Inc. | 1996-01-24 |
| AXSYM PHENYTOIN II (K953840) | Abbott Laboratories | 1995-09-25 |
| TDX(R)/TDXFLX(R) PHENYTOIN II (K946328) | Abbott Laboratories | 1995-03-28 |
| AXSYM PHENYTOIN ASSAY (K935375) | Abbott Laboratories | 1994-06-21 |
| COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS (K936131) | Roche Diagnostic Systems, Inc. | 1994-03-11 |
| OPUS PHENYTOIN TEST SYSTEM (K896868) | Pb Diagnostic Systems, Inc. | 1990-01-02 |
| INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (K895827) | Innotron of Oregon, Inc. | 1989-10-31 |
| INNOTRON INNOFLUOR PHEYTOIN REAGENT SET (K872563) | Innotron of Oregon, Inc. | 1987-08-21 |
| IMMPULSE PHENYTOIN ASSAY REAGENT (K862554) | Sclavo, Inc. | 1986-07-16 |
| COBAS FP REAGENTS FOR PHENYTOIN & CALIBR (K843824) | Roche Diagnostic Systems, Inc. | 1985-02-01 |
| PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE (K844171) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-12-10 |
Recalls involving this device
No recalls on record reference this clearance.