Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Polymedco, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
214 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112408 | POLY-CHEM 90 ISE MODULE | Polymedco, Inc. | 2011-11-04 | 74 | 0 |
| K110818 | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATINI | Polymedco, Inc. | 2011-09-08 | 168 | 0 |
| K111143 | POLY-CHEM 90 TOTAL BILIRUBIN | Polymedco, Inc. | 2011-09-01 | 132 | 0 |
| K100550 | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL | Polymedco, Inc. | 2010-09-28 | 214 | 0 |
| K090703 | POLY-CHEM 90 GLUCOSE | Polymedco, Inc. | 2009-10-20 | 217 | 0 |
| K061944 | POLY-CHEM CREATININE | Polymedco, Inc. | 2006-11-03 | 116 | 0 |
| K053553 | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL | Polymedco, Inc. | 2006-03-09 | 79 | 0 |
| K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | Polymedco, Inc. | 2004-10-21 | 147 | 0 |
| K041297 | POLYMEDCO OC LIGHT FOBT TEST | Polymedco, Inc. | 2004-08-12 | 90 | 1 |
| K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CH | Polymedco, Inc. | 2004-02-04 | 70 | 0 |
| K023654 | GLYCA-DIRECT FRUCTOSAMINE | Polymedco, Inc. | 2003-05-02 | 184 | 0 |
| K020852 | POLY-CHEM GLUCOSE | Polymedco, Inc. | 2002-07-03 | 110 | 0 |
| K020532 | POLYMEDCO HBA1C TEST | Polymedco, Inc. | 2002-04-24 | 64 | 0 |
| K012163 | POLYTITER SYSTEM | Polymedco, Inc. | 2001-08-20 | 40 | 0 |
| K962049 | C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT | Polymedco, Inc. | 1996-12-18 | 204 | 0 |
| K955086 | TEST, RHEUMATOID FACTOR | Polymedco, Inc. | 1995-12-20 | 43 | 0 |
| K924061 | CANCER ANTIGEN CONTROL | Polymedco, Inc. | 1993-02-23 | 195 | 1 |
| K921206 | HCG CONTROL | Polymedco, Inc. | 1992-04-29 | 47 | 0 |
| K915325 | TSH CONTROL | Polymedco, Inc. | 1992-03-02 | 101 | 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