Syn-Kit, Inc.
Mchenry, IL, US
Syn-Kit, Inc. appears in FDA device records in Mchenry, IL. FDA records list 34 510(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
- 34
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 34 510(k) clearances for Syn-Kit, Inc. between 1980 and 1986. The busiest year on record is 1981, with 11. The most recent is 1986, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 3 |
| 1981 | 11 |
| 1982 | 4 |
| 1983 | 1 |
| 1984 | 10 |
| 1985 | 1 |
| 1986 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K861098 | SEROIDEN STREPTO KIT 'EIKEN' | GTZ | Substantially Equivalent | |
| K861631 | SLIDE CULTURE U 'EIKEN' | JXA | Substantially Equivalent | |
| K854819 | CPR SLIDE EIKEN | DCN | Substantially Equivalent | |
| K854820 | RA 80 EIKEN | DHR | Substantially Equivalent | |
| K853276 | ASO SLIDE EIKEN | GTQ | Substantially Equivalent | |
| K843760 | UROPAPER EIKEN G | JIL | Substantially Equivalent | |
| K843759 | UROPAPER EIKEN HAG | JIL | Substantially Equivalent | |
| K843758 | UROPAPER EIKEN GK | JIL | Substantially Equivalent | |
| K843757 | UROPAPER EIKEN AG | JIL | Substantially Equivalent | |
| K843756 | UROPAPER EIKEN 5 | JIL | Substantially Equivalent | |
| K843755 | UROPAPER EIKEN 6B | JIL | Substantially Equivalent | |
| K843754 | UROPAPER EIKEN 7 | JIL | Substantially Equivalent | |
| K843753 | UROPAPER EIKEN GP | JIL | Substantially Equivalent | |
| K843532 | UROPAPER EIKEN 8 | KHE | Substantially Equivalent | |
| K833521 | REAGENT TESTS STRIP COMBINATIONS | JJB | Substantially Equivalent | |
| K830824 | URINE SCREENING KIT | CEN | Substantially Equivalent | |
| K821167 | URICASE (U.V.) URIC ACID | CDO | Substantially Equivalent | |
| K821106 | TRIGLYZYME V EIKEN | JGY | Substantially Equivalent | |
| K821105 | CHOLESTEZYME-V EIKEN | CHH | Substantially Equivalent | |
| K820567 | TREP CARD EIKEN | GMQ | Substantially Equivalent | |
| K813164 | SYSTEK #1 EIKEN | JSS | Substantially Equivalent | |
| K812298 | FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN | GHH | Substantially Equivalent | |
| K811815 | UROPAPER EIKEG | KHE | Substantially Equivalent | |
| K811816 | UROPAPER EIKEN UHAG | JIL | Substantially Equivalent | |
| K813192 | HDL-C EIKEN | LBS | Substantially Equivalent | |
| K811818 | UROPAPER EIKEN UAG | JIL | Substantially Equivalent | |
| K811817 | UROPAPER EIKEN AG | JIL | Substantially Equivalent | |
| K802447 | GOT ISOENZYME ASSAY EIKEN KIT | CIT | Substantially Equivalent | |
| K810862 | CRP SLIDE | DCN | Substantially Equivalent | |
| K802451 | BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC. | JHQ | Substantially Equivalent | |
| K802448 | RA 80 EIKEN KIT DETERM. OF RHEUMATIC F. | DHR | Substantially Equivalent | |
| K802452 | TOXOTEST-MT EIKEN KIT | GMM | Substantially Equivalent | |
| K802454 | GESTE FOLLOW KIT DETERM. OF HPL | JMF | Substantially Equivalent | |
| K802450 | GESTATE SLIDE EIKEN KIT AGG. METHOD HUM | JHJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CDOAcid, Uric, Uricase (U.V.)
- JHJAgglutination Method, Human Chorionic Gonadotropin
- GMMAntigens, Iha, Toxoplasma Gondii
- GMQAntigens, Nontreponemal, All
- GTZAntisera, All Groups, Streptococcus Spp.
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JGYColorimetric Method, Triglycerides
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- GHHFibrin Split Products
- JSSKit, Identification, Enterobacteriaceae
- JXAKit, Screening, Urine
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- JHQNephelometric Method, Lipoproteins
- JMFRadioimmunoassay, Human Placental Lactogen
- KHEReagent, Occult Blood
- DCNSystem, Test, C-Reactive Protein
- DHRSystem, Test, Rheumatoid Factor
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