Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Serim Research Corp. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
224 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120652 | RAPICIDE OPA-28 TEST STRIP | Serim Research Corp. | 2012-10-12 | 224 | 0 |
| K092346 | SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 | Serim Research Corp. | 2010-01-07 | 156 | 0 |
| K083295 | SERIM DISINTEK GTA 2.1%, MODEL: 5164 | Serim Research Corp. | 2009-03-16 | 126 | 0 |
| K082352 | SERIM DISINTEK OPA TEST STRIP | Serim Research Corp. | 2008-09-25 | 40 | 0 |
| K081370 | SERIM DISINTEK OPA TEST STRIP | Serim Research Corp. | 2008-07-11 | 57 | 0 |
| K080712 | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 | Serim Research Corp. | 2008-05-06 | 54 | 0 |
| K052388 | SERIM PERACETIC ACID CHEMICAL INDICATOR | Serim Research Corp. | 2005-12-01 | 92 | 0 |
| K043031 | SERIM DIALYSATE MONITOR TEST STRIP | Serim Research Corp. | 2005-06-13 | 222 | 0 |
| K014038 | PYLORITEK VP TEST KIT 5140VP | Serim Research Corp. | 2002-02-08 | 63 | 0 |
| K012115 | SERIM BLOOD LEAK TEST STRIP-2 | Serim Research Corp. | 2001-11-30 | 147 | 0 |
| K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS | Serim Research Corp. | 2000-05-05 | 73 | 0 |
| K992341 | CIDEX OPA SOLUTION TEST STRIP | Serim Research Corp. | 1999-11-23 | 133 | 0 |
| K990206 | SERIM BLOOD LEAK TEST STRIP | Serim Research Corp. | 1999-04-21 | 90 | 0 |
| K972035 | SPOROX TEST STRIPS | Serim Research Corp. | 1997-08-29 | 88 | 0 |
| K953632 | SERIM PYLORITEK TEST KIT | Serim Research Corp. | 1995-12-18 | 151 | 0 |
| K952215 | SERIM HISENSE TEST KIT | Serim Research Corp. | 1995-08-09 | 90 | 0 |
| K945491 | SERIM(TM) BICARB PH REAGENT STRIPS | Serim Research Corp. | 1995-02-01 | 85 | 0 |
| K932047 | WAVICIDE MONITOR STRIPS | Serim Research Corp. | 1994-06-02 | 401 | 0 |
| K936034 | SERIM PYLORITEK REAGENT STRIPS | Serim Research Corp. | 1994-04-21 | 127 | 0 |
| K914123 | SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS | Serim Research Corp. | 1992-04-09 | 209 | 0 |
| K913943 | SERIM DISINTEK REAGENT STRIPS | Serim Research Corp. | 1992-03-26 | 204 | 0 |
| K911628 | SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) | Serim Research Corp. | 1991-06-27 | 77 | 0 |
| K911629 | SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) | Serim Research Corp. | 1991-06-27 | 77 | 0 |
| K910320 | SERIM PERACETIC ACID REAGENT STRIPS | Serim Research Corp. | 1991-05-01 | 97 | 0 |
| K902227 | SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT | Serim Research Corp. | 1991-04-02 | 320 | 0 |
| K901734 | SERIM RESIDUAL CHLORINE TEST KIT | Serim Research Corp. | 1990-09-13 | 149 | 0 |
| K900341 | SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT | Serim Research Corp. | 1990-07-11 | 170 | 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