Syva Co.
San Jose, CA, US
Syva Co. appears in FDA device records in San Jose, CA. FDA records list 59 510(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
- 59
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 59FDA records hold 59 510(k) clearances for Syva Co. between 1992 and 2001. The busiest year on record is 1992, with 16. The most recent is 2001, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 16 |
| 1993 | 13 |
| 1994 | 5 |
| 1995 | 7 |
| 1999 | 2 |
| 2000 | 14 |
| 2001 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K011528 | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 | DLZ | Substantially Equivalent | |
| K011347 | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 | DIP | Substantially Equivalent | |
| K993981 | SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL | JXN | Substantially Equivalent | |
| K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | DML | Substantially Equivalent | |
| K993988 | SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL | DIO | Substantially Equivalent | |
| K993987 | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL | KLT | Substantially Equivalent | |
| K993986 | SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL | KXS | Substantially Equivalent | |
| K993985 | SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL | JXM | Substantially Equivalent | |
| K993983 | SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL | LCM | Substantially Equivalent | |
| K993982 | SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL | LAF | Substantially Equivalent | |
| K993031 | ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 | DLZ | Substantially Equivalent | |
| K993029 | ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 | KLS | Substantially Equivalent | |
| K993028 | ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 | KLT | Substantially Equivalent | |
| K993026 | ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS | DIP | Substantially Equivalent | |
| K994005 | SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL | DJR | Substantially Equivalent | |
| K993984 | SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL | LDJ | Substantially Equivalent | |
| K993755 | EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 | DKB | Substantially Equivalent | |
| K984232 | MODIFICATION OF EMIT D.A.U. OPIATES ASSAY | DJG | Substantially Equivalent | |
| K951755 | EMIT 2000 DIGOXIN ASSAY | KXT | Substantially Equivalent | |
| K935192 | EMIT IIC CALIBRATORS | DKB | Substantially Equivalent | |
| K940158 | EMIT IIC CANNABINOID ASSAY | LDJ | Substantially Equivalent | |
| K935352 | EMIT(R) IIC AMPHETAMINE ASSAY | DKZ | Substantially Equivalent | |
| K935323 | EMIT IIC COCAINE METABOLITE ASSAY | DIO | Substantially Equivalent | |
| K935191 | EMIT IIC PHENCYCLIDINE ASSAY | LCM | Substantially Equivalent | |
| K935116 | EMIT IIC BARBITURATE ASSAY | DIS | Substantially Equivalent | |
| K943500 | EMIT 2000 DIGOXIN ASSAY | KXT | Substantially Equivalent | |
| K942619 | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS | LFM | Substantially Equivalent | |
| K941235 | VISTA B12 ASSAY | CDD | Substantially Equivalent | |
| K934135 | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION | KXT | Substantially Equivalent | |
| K935117 | EMIT(R) IIC OPIATE ASSAY | DJG | Substantially Equivalent | |
| K934121 | VISTA FOLATE ASSAY | CGN | Substantially Equivalent | |
| K932716 | EMIT(R) THC 50/100 NG ASSAY | LDJ | Substantially Equivalent | |
| K926090 | SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT | LJC | Substantially Equivalent | |
| K931576 | VISTA FERRITIN ASSAY | DBF | Substantially Equivalent | |
| K931123 | DIGOXIN TEST SYSTEM, KXT TX | KXT | Substantially Equivalent | |
| K931535 | EMIT(R) D.A.U. BARBITURATE ASSAY | DIS | Substantially Equivalent | |
| K926422 | VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY | GGJ | Substantially Equivalent | |
| K926394 | VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY | CEP | Substantially Equivalent | |
| K931536 | EMIT(R) D.A.U. BENZODIAZEPINE ASSAY | JXM | Substantially Equivalent | |
| K926386 | VISTA PROLACTIN ASSAY | CFT | Substantially Equivalent | |
| K926342 | VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY | JHI | Substantially Equivalent | |
| K926068 | EMIT(R) II BARBITURATE ASSAY | DIS | Substantially Equivalent | |
| K926067 | EMIT(R) II BENZODIAZEPINE ASSAY | JXM | Substantially Equivalent | |
| K923572 | VISTA FREE THYROXINE ASSAY | CEC | Substantially Equivalent | |
| K923873 | SYVA EMIT II PROPOXYPHENE ASSAY | JXN | Substantially Equivalent | |
| K923571 | VISTA TRIIODOTHYRONINE ASSAY | CDP | Substantially Equivalent | |
| K923676 | VISTA THYROXINE UPTAKE ASSAY | KHQ | Substantially Equivalent | |
| K921747 | MICRO TRAK XL SYSTEM | LJC | Substantially Equivalent | |
| K921462 | MICROTRAK(R) II CHLAMYDIA EIA ASSAY | LJC | Substantially Equivalent | |
| K920503 | SYVA MICROTRAK CHLAMYDIA EIA | LJC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- DKBCalibrators, Drug Mixture
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- KLTEnzyme Immunoassay, Carbamazepine
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- LFMEnzyme Immunoassay, Digitoxin
- KXTEnzyme Immunoassay, Digoxin
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DJREnzyme Immunoassay, Methadone
- LANEnzyme Immunoassay, N-Acetylprocainamide
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- DLZEnzyme Immunoassay, Phenobarbital
- LAREnzyme Immunoassay, Procainamide
- JXNEnzyme Immunoassay, Propoxyphene
- LBZEnzyme Immunoassay, Quinidine
- KLSEnzyme Immunoassay, Theophylline
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- DBFFerritin, Antigen, Antiserum, Control
- GGJFluid, Diluting, White-Cell
- LAFGas Chromatography, Methamphetamine
- DMLNad-Nadh, Specific Reagent For Alcohol Enzyme Method
- KHQRadioassay, Triiodothyronine Uptake
- CDDRadioassay, Vitamin B12
- CECRadioimmunoassay, Free Thyroxine
- CEPRadioimmunoassay, Luteinizing Hormone
- KXSRadioimmunoassay, Methaqualone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- JHIVisual, Pregnancy Hcg, Prescription Use
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