KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
FDA 510(k) clearance K942610 · decided 1994-10-20
Clearance details
- K-number
- K942610
- Device name
- KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1994-06-02
- Decision date
- 1994-10-20
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- LFM
- Device class
- 2
- Regulation number
- 862.3300
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE (K062024) | Dade Behring, Inc. | 2006-07-28 |
| RANDOX DIGITOXIN (K012112) | Randox Laboratories, Ltd. | 2002-01-11 |
| DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 (K990251) | Dade Behring, Inc. | 1999-03-31 |
| ACS DIGITOXIN (K970546) | Chiron Diagnostics Corp. | 1997-07-14 |
| ABBOTT AXSYM DIGITOXIN (MODIFY) (K963158) | Abbott Laboratories | 1996-09-10 |
| AXSYM DIGITOXIN (K954420) | Abbott Laboratories | 1995-12-29 |
| DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K951631) | Bayer Corp. | 1995-06-09 |
| IMMULITE DIGITOXIN (K943235) | Diagnostic Products Corp. | 1994-10-27 |
| EMIT 2000 DIGOXIN ASSAY/CALIBRATORS (K942619) | Syva Co. | 1994-09-20 |
| DIGITOXIN FPIA REAGENT SET (K915465) | Sigma Diagnostics, Inc. | 1992-01-27 |
| INNOFLUOR(TM) DIGITOXIN REAGENT SET (K913187) | Intl. Bioclinical, Inc. | 1991-09-23 |
| DIGITOXIN (FPIA) KIT (K913240) | Tudor Laboratories, Inc. | 1991-09-06 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides recall (Z-0901-2025) | QUIDEL ORTHO | 2025-01-10 |
| Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides recall (Z-0902-2025) | QUIDEL ORTHO | 2025-01-10 |
| VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VI recall (Z-0310-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box wit recall (Z-2211-2012) | Ortho-Clinical Diagnostics | 2012-08-15 |