Syva Co.
Palo Alto, CA, US
Syva Co. appears in FDA device records in Palo Alto, CA. FDA records list 140 510(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
- 140
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 140FDA records hold 140 510(k) clearances for Syva Co. between 1984 and 1992. The busiest year on record is 1985, with 26. The most recent is 1992, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 2 |
| 1985 | 26 |
| 1986 | 12 |
| 1987 | 24 |
| 1988 | 26 |
| 1989 | 13 |
| 1990 | 20 |
| 1991 | 15 |
| 1992 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K915501 | EMIT D.A.U BENZODIAZEPINE ASSAY | JXM | Substantially Equivalent | |
| K915728 | EMIT D.A.U. PHENCYCLIDINE ASSAY | LCM | Substantially Equivalent | |
| K915003 | EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) | DKB | Substantially Equivalent | |
| K914973 | SYVA EMIT D.A.U. COCAINE METABOLITE | DIO | Substantially Equivalent | |
| K913840 | MICROTAK PLUS | JJQ | Substantially Equivalent | |
| K913123 | EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS | KLS | Substantially Equivalent | |
| K913410 | EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS | DMB | Substantially Equivalent | |
| K913429 | EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS | DIP | Substantially Equivalent | |
| K913190 | EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS | DLZ | Substantially Equivalent | |
| K913066 | EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS | KLT | Substantially Equivalent | |
| K912959 | MICROTRAK MANAGER | JJQ | Substantially Equivalent | |
| K912729 | EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH) | DKB | Substantially Equivalent | |
| K912055 | SYVA EDMS | JJF | Substantially Equivalent | |
| K910527 | EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE | DJD | Substantially Equivalent | |
| K905179 | SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION | LJC | Substantially Equivalent | |
| K910376 | EMIT II BENZODIAZEPINE ASSAY | JXM | Substantially Equivalent | |
| K904990 | EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS | LBZ | Substantially Equivalent | |
| K904571 | EMIT(R) II CANNABINOID 50 NG ASSAY | LDJ | Substantially Equivalent | |
| K904570 | EMIT(R) II CANNABINOID 20 NG ASSAY | LDJ | Substantially Equivalent | |
| K904569 | EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS | DLJ | Substantially Equivalent | |
| K904568 | EMIT(R) II CANNABINOID 100 NG ASSAY | LDJ | Substantially Equivalent | |
| K904765 | EMIT (R) II PHENCYCLIDINE ASSAY | LCM | Substantially Equivalent | |
| K904764 | EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) | DKB | Substantially Equivalent | |
| K903357 | SYVA(R) ETS(R) PLUS SYSTEM | JJF | Substantially Equivalent | |
| K903758 | SYVA MICROTRAK EIA ACCESSORY REAGENTS | LJC | Substantially Equivalent | |
| K903228 | EMIT ETS PLUS ETHYL ALCOHOL ASSAY | DMI | Substantially Equivalent | |
| K903152 | EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS | DKB | Substantially Equivalent | |
| K903153 | EMIT ETHYL ALCOHOL ASSAY | DIC | Substantially Equivalent | |
| K902581 | EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE) | DKB | Substantially Equivalent | |
| K902579 | EMIT(R) II COCAINE METABOLITE ASSAY | DIO | Substantially Equivalent | |
| K902577 | EMIT(R) II OPIATE ASSAY | DJG | Substantially Equivalent | |
| K902580 | EMIT(R) II BARBITURATE ASSAY | DIS | Substantially Equivalent | |
| K902578 | EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2 | DKB | Substantially Equivalent | |
| K901573 | EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B | DKB | Substantially Equivalent | |
| K900995 | EMIT D.A.U. AMPHETAMINE CLASS ASSAY | DKZ | Substantially Equivalent | |
| K897114 | EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY | KLT | Substantially Equivalent | |
| K896070 | PFEIFFER METERED DOSAGE SYSTEM | CCQ | Substantially Equivalent | |
| K894145 | EMIT T-UPTAKE ASSAY | KHQ | Substantially Equivalent | |
| K893910 | EMIT CONVENIENCE PACK: DIGOXIN ASSAY | KXT | Substantially Equivalent | |
| K894404 | EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE | DKZ | Substantially Equivalent | |
| K892060 | CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM | JQP | Substantially Equivalent | |
| K894327 | EMIT D.A.U. LOW & MEDIUM CALIBRATOR A | DKG | Substantially Equivalent | |
| K891270 | MICROTRAK EIA AUTOREADER | JJQ | Substantially Equivalent | |
| K891269 | MICROTRAK EIA AUTOWASHER | JYC | Substantially Equivalent | |
| K890831 | EMIT CONVENIENCE PACK: THYROXINE ASSAY | KLI | Substantially Equivalent | |
| K885253 | ACCULEVEL ONE-STEP THEOPHYLLINE TEST | KLS | Substantially Equivalent | |
| K890196 | MICROTRAK CHLAMYDIA EIA | LJC | Substantially Equivalent | |
| K885141 | EMIT THYROXINE ASSAY | KLI | Substantially Equivalent | |
| K890452 | EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR | DLJ | Substantially Equivalent | |
| K890451 | EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR | DLJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GONAntigen, Cf (Including Cf Control), Rubella
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- GTHAntiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- KIEApparatus, High Pressure Liquid Chromatography
- JQPCalculator/Data Processing Module, For Clinical Use
- DKBCalibrators, Drug Mixture
- DLJCalibrators, Drug Specific
- JYCCannula, Ear
- KZRChromatography (Liquid, Gel), Clinical Use
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- LDPColorimetry, Acetaminophen
- JSMCulture Media, Non-Propagating Transport
- LIODevice, Specimen Collection
- DIFDrug Mixture Control Materials
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- KLTEnzyme Immunoassay, Carbamazepine
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- KXTEnzyme Immunoassay, Digoxin
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DLFEnzyme Immunoassay, Ethosuximide
- LCDEnzyme Immunoassay, Gentamicin
- DJREnzyme Immunoassay, Methadone
- LANEnzyme Immunoassay, N-Acetylprocainamide
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- DLZEnzyme Immunoassay, Phenobarbital
- DJDEnzyme Immunoassay, Primidone
- LAREnzyme Immunoassay, Procainamide
- JXNEnzyme Immunoassay, Propoxyphene
- LBZEnzyme Immunoassay, Quinidine
- KLSEnzyme Immunoassay, Theophylline
- LEGEnzyme Immunoassay, Valproic Acid
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LESFluorescent Immunoassay, Diphenylhydantoin
- DMBGas Chromatography, Methadone
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- DKGPlate, Cellulose, Tlc
- DMIPotassium Dichromate Specific Reagent For Alcohol
- KHQRadioassay, Triiodothyronine Uptake
- KXSRadioimmunoassay, Methaqualone
- LCLRadioimmunoassay, Phencyclidine
- KLBRadioimmunoassay, Tobramycin
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- LEHRadioimmunoassay, Vancomycin
- KEAResins, Ion-Exchange
- 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