Company ยท US
Syn-Kit, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1986. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 11 |
| DCN | System, Test, C-Reactive Protein | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 |
| KHE | Reagent, Occult Blood | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| GHH | Fibrin Split Products | 1 |
| GMM | Antigens, Iha, Toxoplasma Gondii | 1 |
| GMQ | Antigens, Nontreponemal, All | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| JGY | Colorimetric Method, Triglycerides | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 |
| JHQ | Nephelometric Method, Lipoproteins | 1 |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | 1 |
| JMF | Radioimmunoassay, Human Placental Lactogen | 1 |
| JSS | Kit, Identification, Enterobacteriaceae | 1 |
| JXA | Kit, Screening, Urine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 12, 1986 | K861098 | SEROIDEN STREPTO KIT 'EIKEN' Syn-Kit, Inc. | GTZ |
| Jun 10, 1986 | K861631 | SLIDE CULTURE U 'EIKEN' Syn-Kit, Inc. | JXA |
| Feb 26, 1986 | K854819 | CPR SLIDE EIKEN Syn-Kit, Inc. | DCN |
| Jan 17, 1986 | K854820 | RA 80 EIKEN Syn-Kit, Inc. | DHR |
| Aug 20, 1985 | K853276 | ASO SLIDE EIKEN Syn-Kit, Inc. | GTQ |
| Dec 18, 1984 | K843760 | UROPAPER EIKEN G Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843759 | UROPAPER EIKEN HAG Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843758 | UROPAPER EIKEN GK Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843757 | UROPAPER EIKEN AG Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843756 | UROPAPER EIKEN 5 Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843755 | UROPAPER EIKEN 6B Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843754 | UROPAPER EIKEN 7 Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843753 | UROPAPER EIKEN GP Syn-Kit, Inc. | JIL |
| Dec 12, 1984 | K843532 | UROPAPER EIKEN 8 Syn-Kit, Inc. | KHE |
| Jan 11, 1984 | K833521 | REAGENT TESTS STRIP COMBINATIONS Syn-Kit, Inc. | JJB |
| Jun 12, 1983 | K830824 | URINE SCREENING KIT Syn-Kit, Inc. | CEN |
| May 14, 1982 | K821167 | URICASE (U.V.) URIC ACID Syn-Kit, Inc. | CDO |
| May 5, 1982 | K821106 | TRIGLYZYME V EIKEN Syn-Kit, Inc. | JGY |
| May 5, 1982 | K821105 | CHOLESTEZYME-V EIKEN Syn-Kit, Inc. | CHH |
| Apr 14, 1982 | K820567 | TREP CARD EIKEN Syn-Kit, Inc. | GMQ |
| Dec 31, 1981 | K813164 | SYSTEK #1 EIKEN Syn-Kit, Inc. | JSS |
| Dec 17, 1981 | K812298 | FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN Syn-Kit, Inc. | GHH |
| Dec 10, 1981 | K811815 | UROPAPER EIKEG Syn-Kit, Inc. | KHE |
| Dec 8, 1981 | K811816 | UROPAPER EIKEN UHAG Syn-Kit, Inc. | JIL |
| Nov 27, 1981 | K813192 | HDL-C EIKEN Syn-Kit, Inc. | LBS |
| Jul 23, 1981 | K811818 | UROPAPER EIKEN UAG Syn-Kit, Inc. | JIL |
| Jul 15, 1981 | K811817 | UROPAPER EIKEN AG Syn-Kit, Inc. | JIL |
| Apr 17, 1981 | K802447 | GOT ISOENZYME ASSAY EIKEN KIT Syn-Kit, Inc. | CIT |
| Apr 8, 1981 | K810862 | CRP SLIDE Syn-Kit, Inc. | DCN |
| Jan 9, 1981 | K802451 | BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC. Syn-Kit, Inc. | JHQ |
| Jan 5, 1981 | K802448 | RA 80 EIKEN KIT DETERM. OF RHEUMATIC F. Syn-Kit, Inc. | DHR |
| Dec 18, 1980 | K802452 | TOXOTEST-MT EIKEN KIT Syn-Kit, Inc. | GMM |
| Nov 12, 1980 | K802454 | GESTE FOLLOW KIT DETERM. OF HPL Syn-Kit, Inc. | JMF |
| Oct 31, 1980 | K802450 | GESTATE SLIDE EIKEN KIT AGG. METHOD HUM Syn-Kit, Inc. | JHJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||