Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Syn-Kit, Inc. — Predicate Candidate Screening
34 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
141 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861098 | SEROIDEN STREPTO KIT 'EIKEN' | Syn-Kit, Inc. | 1986-08-12 | 141 | 0 |
| K861631 | SLIDE CULTURE U 'EIKEN' | Syn-Kit, Inc. | 1986-06-10 | 42 | 0 |
| K854819 | CPR SLIDE EIKEN | Syn-Kit, Inc. | 1986-02-26 | 85 | 0 |
| K854820 | RA 80 EIKEN | Syn-Kit, Inc. | 1986-01-17 | 45 | 0 |
| K853276 | ASO SLIDE EIKEN | Syn-Kit, Inc. | 1985-08-20 | 15 | 0 |
| K843754 | UROPAPER EIKEN 7 | Syn-Kit, Inc. | 1984-12-18 | 84 | 0 |
| K843760 | UROPAPER EIKEN G | Syn-Kit, Inc. | 1984-12-18 | 84 | 0 |
| K843756 | UROPAPER EIKEN 5 | Syn-Kit, Inc. | 1984-12-18 | 84 | 0 |
| K843758 | UROPAPER EIKEN GK | Syn-Kit, Inc. | 1984-12-18 | 84 | 0 |
| K843757 | UROPAPER EIKEN AG | Syn-Kit, Inc. | 1984-12-18 | 84 | 0 |
| K843753 | UROPAPER EIKEN GP | Syn-Kit, Inc. | 1984-12-18 | 84 | 0 |
| K843755 | UROPAPER EIKEN 6B | Syn-Kit, Inc. | 1984-12-18 | 84 | 0 |
| K843759 | UROPAPER EIKEN HAG | Syn-Kit, Inc. | 1984-12-18 | 84 | 0 |
| K843532 | UROPAPER EIKEN 8 | Syn-Kit, Inc. | 1984-12-12 | 96 | 0 |
| K833521 | REAGENT TESTS STRIP COMBINATIONS | Syn-Kit, Inc. | 1984-01-11 | 92 | 0 |
| K830824 | URINE SCREENING KIT | Syn-Kit, Inc. | 1983-06-12 | 89 | 0 |
| K821167 | URICASE (U.V.) URIC ACID | Syn-Kit, Inc. | 1982-05-14 | 17 | 0 |
| K821105 | CHOLESTEZYME-V EIKEN | Syn-Kit, Inc. | 1982-05-05 | 15 | 0 |
| K821106 | TRIGLYZYME V EIKEN | Syn-Kit, Inc. | 1982-05-05 | 15 | 0 |
| K820567 | TREP CARD EIKEN | Syn-Kit, Inc. | 1982-04-14 | 43 | 0 |
| K813164 | SYSTEK #1 EIKEN | Syn-Kit, Inc. | 1981-12-31 | 51 | 0 |
| K812298 | FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN | Syn-Kit, Inc. | 1981-12-17 | 125 | 0 |
| K811815 | UROPAPER EIKEG | Syn-Kit, Inc. | 1981-12-10 | 167 | 0 |
| K811816 | UROPAPER EIKEN UHAG | Syn-Kit, Inc. | 1981-12-08 | 165 | 0 |
| K813192 | HDL-C EIKEN | Syn-Kit, Inc. | 1981-11-27 | 10 | 0 |
| K811818 | UROPAPER EIKEN UAG | Syn-Kit, Inc. | 1981-07-23 | 27 | 0 |
| K811817 | UROPAPER EIKEN AG | Syn-Kit, Inc. | 1981-07-15 | 19 | 0 |
| K802447 | GOT ISOENZYME ASSAY EIKEN KIT | Syn-Kit, Inc. | 1981-04-17 | 191 | 0 |
| K810862 | CRP SLIDE | Syn-Kit, Inc. | 1981-04-08 | 8 | 0 |
| K802451 | BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC. | Syn-Kit, Inc. | 1981-01-09 | 93 | 0 |
| K802448 | RA 80 EIKEN KIT DETERM. OF RHEUMATIC F. | Syn-Kit, Inc. | 1981-01-05 | 89 | 0 |
| K802452 | TOXOTEST-MT EIKEN KIT | Syn-Kit, Inc. | 1980-12-18 | 71 | 0 |
| K802454 | GESTE FOLLOW KIT DETERM. OF HPL | Syn-Kit, Inc. | 1980-11-12 | 35 | 0 |
| K802450 | GESTATE SLIDE EIKEN KIT AGG. METHOD HUM | Syn-Kit, Inc. | 1980-10-31 | 23 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda