Syva Co., Dade Behring, Inc.
San Jose, CA, US
Syva Co., Dade Behring, Inc. appears in FDA device records in San Jose, CA. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Syva Co., Dade Behring, Inc. between 2000 and 2001. The busiest year on record is 2001, with 18. The most recent is 2001, with 18.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 18 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K011920 | EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 | KXT | Substantially Equivalent | |
| K011620 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 | LAN | Substantially Equivalent | |
| K011605 | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 | LBZ | Substantially Equivalent | |
| K011300 | EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 | LDJ | Substantially Equivalent | |
| K011306 | EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 | JXM | Substantially Equivalent | |
| K011289 | EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 | DJG | Substantially Equivalent | |
| K011161 | MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 | LCM | Substantially Equivalent | |
| K011166 | MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 | KLS | Substantially Equivalent | |
| K011164 | MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 | KXS | Substantially Equivalent | |
| K011163 | MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 | JXN | Substantially Equivalent | |
| K011162 | MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY | DIO | Substantially Equivalent | |
| K010962 | EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 | DJR | Substantially Equivalent | |
| K010960 | EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 | DIC | Substantially Equivalent | |
| K010984 | EMIT 2000 GENTAMICIN PLUS ASSAY | LCD | Substantially Equivalent | |
| K010934 | EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 | DIS | Substantially Equivalent | |
| K010814 | EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 | KLT | Substantially Equivalent | |
| K010812 | EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 | LAR | Substantially Equivalent | |
| K003341 | EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS | KLB | Substantially Equivalent | |
| K000600 | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS | KLI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- KLTEnzyme Immunoassay, Carbamazepine
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- KXTEnzyme Immunoassay, Digoxin
- LCDEnzyme Immunoassay, Gentamicin
- DJREnzyme Immunoassay, Methadone
- LANEnzyme Immunoassay, N-Acetylprocainamide
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- LAREnzyme Immunoassay, Procainamide
- JXNEnzyme Immunoassay, Propoxyphene
- LBZEnzyme Immunoassay, Quinidine
- KLSEnzyme Immunoassay, Theophylline
- KXSRadioimmunoassay, Methaqualone
- KLBRadioimmunoassay, Tobramycin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain