Syva Co.
Walker, MI, US
Syva Co. appears in FDA device records in Walker, MI. FDA records list 33 510(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
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Syva Co. between 1977 and 1984. The busiest year on record is 1984, with 10. The most recent is 1984, with 10.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 2 |
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 5 |
| 1982 | 7 |
| 1983 | 3 |
| 1984 | 10 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K843605 | EMIT 700 METHAQUALONE ASSAY | KXS | Substantially Equivalent | |
| K834457 | EMIT D.A.U. URINE CANNABINOID CALIBRA | DLJ | Substantially Equivalent | |
| K834458 | EMIT D.A.U. URINE CANNABINOID ASSAY | LDJ | Substantially Equivalent | |
| K841191 | MICROTRAKSPECIMAN ID TYPING TEST CONTR | GQN | Substantially Equivalent | |
| K840494 | MICROTRAK HSV 1 & 2 CULTURE | GQL | Substantially Equivalent | |
| K840236 | EMIT ST SERUM BENZODIAZEPINE ASSAY | JXM | Substantially Equivalent | |
| K840194 | EMIT ST SERUM BARBITURATE ASSAY | DIS | Substantially Equivalent | |
| K834549 | EMIT ST. URINE COCAINE METABOLITE | DIO | Substantially Equivalent | |
| K833578 | MODIF. OF EMIT URINE BENZODIAZEPINE | JXM | Substantially Equivalent | |
| K834216 | EMIT QST PHENOBARBITAL ASSAY | DLZ | Substantially Equivalent | |
| K833932 | SYVA ADVANCE CORTISOL ASSAY | JFT | Substantially Equivalent | |
| K831272 | EMIT QST THEOPHYLLINE ASSAY | KLS | Substantially Equivalent | |
| K823866 | ADVANCE EMIT CAD LIDOCAINE ASSAY | KLR | Substantially Equivalent | |
| K823567 | IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM | CZP | Substantially Equivalent | |
| K823566 | IMMUNOGLOBULIN CONTROL | CZP | Substantially Equivalent | |
| K821186 | PENETRAK TM | GKZ | Substantially Equivalent | |
| K821380 | EMIT TOX ACETAMINOPHEN CONTROL | LAS | Substantially Equivalent | |
| K820462 | EMIT-ST URINE CONTROLS SET A #3A349 | DIF | Substantially Equivalent | |
| K820461 | EMIT-ST URINE CALIBRATOR A (#3A319 | DKB | Substantially Equivalent | |
| K820188 | PHENOBARBITAL ASSAY | LET | Substantially Equivalent | |
| K812197 | EMIT-ST CANNABINOID CALIBRATOR | DLJ | Substantially Equivalent | |
| K812196 | EMIT-ST CANNABINOID CONTROLS | LAS | Substantially Equivalent | |
| K812195 | EMIT-ST CANNABINOID ASSAY | LDJ | Substantially Equivalent | |
| K811622 | EMIT-ST SERUM PHENOBARBITAL CALIBRATOR | DLJ | Substantially Equivalent | |
| K811619 | EMIT-ST SERUM PHENOBARBITAL CONTROLS | LAS | Substantially Equivalent | |
| K801476 | APPLICATION OF EMIT THEOPHYLLINE ASSAY | KLS | Substantially Equivalent | |
| K790937 | EMIT AUTO DIGOXIN ASSAY | KXT | Substantially Equivalent | |
| K790398 | EMIT-D.A.U. PHENCYCLIDINE URINE LOW | DLJ | Substantially Equivalent | |
| K782085 | EMIT THYROXINE ASSAY | KLI | Substantially Equivalent | |
| K780639 | EMIT CENTRIFICHEM THYROXINE ASSAY | CDX | Substantially Equivalent | |
| K780467 | EMIT ANTIEPILEPTIC DRUG CALIBRATORS | JIS | Substantially Equivalent | |
| K772179 | EMIT ANTIEPILEPTIC DRUG ASSAYS | DIP | Substantially Equivalent | |
| K770070 | ENIT ABA THYROXINE ASSAY | KLI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- JISCalibrator, Primary
- DKBCalibrators, Drug Mixture
- DLJCalibrators, Drug Specific
- GKZCounter, Differential Cell
- DIFDrug Mixture Control Materials
- LASDrug Specific Control Materials
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- KXTEnzyme Immunoassay, Digoxin
- DIPEnzyme Immunoassay, Diphenylhydantoin
- KLREnzyme Immunoassay, Lidocaine
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DLZEnzyme Immunoassay, Phenobarbital
- KLSEnzyme Immunoassay, Theophylline
- LETFluorescent Immunoassay, Phenobarbital
- JFTFluorometric, Cortisol
- CZPIga, Antigen, Antiserum, Control
- KXSRadioimmunoassay, Methaqualone
- CDXRadioimmunoassay, Total Thyroxine
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