Company ยท US
Syva Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2001. Name variants (Inc, Corp, punctuation) are merged.
448510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LAS | Drug Specific Control Materials | 22 |
| DKB | Calibrators, Drug Mixture | 21 |
| DLJ | Calibrators, Drug Specific | 18 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 17 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 14 |
| DIF | Drug Mixture Control Materials | 13 |
| DIS | Enzyme Immunoassay, Barbiturate | 13 |
| DKZ | Enzyme Immunoassay, Amphetamine | 13 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 13 |
| KLT | Enzyme Immunoassay, Carbamazepine | 12 |
| KLS | Enzyme Immunoassay, Theophylline | 11 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 10 |
| KXT | Enzyme Immunoassay, Digoxin | 10 |
| LCM | Enzyme Immunoassay, Phencyclidine | 10 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 9 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 9 |
| DJG | Enzyme Immunoassay, Opiates | 8 |
| DLZ | Enzyme Immunoassay, Phenobarbital | 8 |
| LAR | Enzyme Immunoassay, Procainamide | 8 |
| LCD | Enzyme Immunoassay, Gentamicin | 8 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2001 | K011878 | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL Syva Co. | DKJ |
| Aug 3, 2001 | K012257 | EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 Syva Co. | DKZ |
| Jul 2, 2001 | K011947 | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL Syva Co. | LEG |
| Jun 6, 2001 | K011528 | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 Syva Co. | DLZ |
| May 17, 2001 | K011347 | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 Syva Co. | DIP |
| Feb 1, 2000 | K993981 | SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL Syva Co. | JXN |
| Feb 1, 2000 | K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL Syva Co. | DML |
| Jan 27, 2000 | K993988 | SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL Syva Co. | DIO |
| Jan 27, 2000 | K993987 | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL Syva Co. | KLT |
| Jan 27, 2000 | K993986 | SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL Syva Co. | KXS |
| Jan 27, 2000 | K993985 | SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL Syva Co. | JXM |
| Jan 27, 2000 | K993983 | SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL Syva Co. | LCM |
| Jan 27, 2000 | K993982 | SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL Syva Co. | LAF |
| Jan 27, 2000 | K993031 | ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 Syva Co. | DLZ |
| Jan 27, 2000 | K993029 | ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 Syva Co. | KLS |
| Jan 27, 2000 | K993028 | ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 Syva Co. | KLT |
| Jan 27, 2000 | K993026 | ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS Syva Co. | DIP |
| Jan 20, 2000 | K994005 | SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL Syva Co. | DJR |
| Jan 18, 2000 | K993984 | SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL Syva Co. | LDJ |
| Dec 21, 1999 | K993755 | EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 Syva Co. | DKB |
| Jan 22, 1999 | K984232 | MODIFICATION OF EMIT D.A.U. OPIATES ASSAY Syva Co. | DJG |
| Jun 1, 1995 | K951755 | EMIT 2000 DIGOXIN ASSAY Syva Co. | KXT |
| Mar 24, 1995 | K935192 | EMIT IIC CALIBRATORS Syva Co. | DKB |
| Feb 22, 1995 | K940158 | EMIT IIC CANNABINOID ASSAY Syva Co. | LDJ |
| Feb 22, 1995 | K935352 | EMIT(R) IIC AMPHETAMINE ASSAY Syva Co. | DKZ |
| Feb 22, 1995 | K935323 | EMIT IIC COCAINE METABOLITE ASSAY Syva Co. | DIO |
| Feb 22, 1995 | K935191 | EMIT IIC PHENCYCLIDINE ASSAY Syva Co. | LCM |
| Feb 22, 1995 | K935116 | EMIT IIC BARBITURATE ASSAY Syva Co. | DIS |
| Nov 15, 1994 | K943500 | EMIT 2000 DIGOXIN ASSAY Syva Co. | KXT |
| Sep 20, 1994 | K942619 | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS Syva Co. | LFM |
| Aug 15, 1994 | K941235 | VISTA B12 ASSAY Syva Co. | CDD |
| Apr 6, 1994 | K934135 | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION Syva Co. | KXT |
| Jan 6, 1994 | K935117 | EMIT(R) IIC OPIATE ASSAY Syva Co. | DJG |
| Jan 3, 1994 | K935230 | EMIT IIC NEGATIVE CONTROL, CONTROL I AND II Syva Co. | DIF |
| Oct 22, 1993 | K934121 | VISTA FOLATE ASSAY Syva Co. | CGN |
| Oct 1, 1993 | K932716 | EMIT(R) THC 50/100 NG ASSAY Syva Co. | LDJ |
| Sep 30, 1993 | K926090 | SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT Syva Co. | LJC |
| Aug 5, 1993 | K931576 | VISTA FERRITIN ASSAY Syva Co. | DBF |
| Aug 5, 1993 | K931123 | DIGOXIN TEST SYSTEM, KXT TX Syva Co. | KXT |
| Jun 15, 1993 | K931535 | EMIT(R) D.A.U. BARBITURATE ASSAY Syva Co. | DIS |
| Jun 2, 1993 | K926422 | VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY Syva Co. | GGJ |
| May 26, 1993 | K926394 | VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY Syva Co. | CEP |
| May 11, 1993 | K931536 | EMIT(R) D.A.U. BENZODIAZEPINE ASSAY Syva Co. | JXM |
| Mar 29, 1993 | K926386 | VISTA PROLACTIN ASSAY Syva Co. | CFT |
| Feb 17, 1993 | K926342 | VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY Syva Co. | JHI |
| Jan 12, 1993 | K926068 | EMIT(R) II BARBITURATE ASSAY Syva Co. | DIS |
| Jan 12, 1993 | K926067 | EMIT(R) II BENZODIAZEPINE ASSAY Syva Co. | JXM |
| Nov 16, 1992 | K923572 | VISTA FREE THYROXINE ASSAY Syva Co. | CEC |
| Nov 2, 1992 | K923873 | SYVA EMIT II PROPOXYPHENE ASSAY Syva Co. | JXN |
| Oct 15, 1992 | K923571 | VISTA TRIIODOTHYRONINE ASSAY Syva Co. | CDP |
Newest 50 of 448.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||