Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Bio Medica Corp. · Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
234 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170222 | Rapid Tox Cup II | American Bio Medica Corp. | 2017-08-15 | 202 | 0 |
| K073078 | RAPID TOX CUP | American Bio Medica Corp. | 2008-05-30 | 212 | 0 |
| K060760 | RAPIDONE-BUPRENORPHINE TEST | American Bio Medica Corp. | 2006-08-07 | 139 | 0 |
| K053422 | RAPIDONE-COCAINE-150 TEST | American Bio Medica Corp. | 2006-06-15 | 189 | 0 |
| K053359 | RAPIDTOX | American Bio Medica Corp. | 2006-05-25 | 174 | 0 |
| K041696 | RAPID READER | American Bio Medica Corp. | 2005-07-12 | 385 | 0 |
| K041712 | 'RAPIDTEC 4' TEST | American Bio Medica Corp. | 2004-11-03 | 133 | 0 |
| K030835 | 'RAPID ONE' - PROPOXYPHENE TEST | American Bio Medica Corp. | 2003-05-22 | 66 | 0 |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE DIP TEST | American Bio Medica Corp. | 2003-04-30 | 161 | 0 |
| K021114 | 'RAPIDTEC' 5A MULTIPLE DIP TEST | American Bio Medica Corp. | 2002-07-23 | 109 | 0 |
| K014101 | RAPIDONE-OXY TEST | American Bio Medica Corp. | 2002-03-20 | 97 | 0 |
| K013180 | RAPIDONE-ECSTASY TEST | American Bio Medica Corp. | 2001-11-26 | 63 | 0 |
| K012164 | 'RAPIDONE'-METHADONE TEST | American Bio Medica Corp. | 2001-11-20 | 132 | 0 |
| K012159 | RAPID DRUG SCREEN | American Bio Medica Corp. | 2001-07-25 | 33 | 0 |
| K002447 | MODIFICATION TO RAPID DRUG SCREEN 9-PANEL | American Bio Medica Corp. | 2000-11-16 | 99 | 0 |
| K992720 | RAPIDONE- BENZODIAZEPINE TEST | American Bio Medica Corp. | 2000-04-03 | 234 | 0 |
| K992451 | RAPIDONE- BARBITURATE TEST | American Bio Medica Corp. | 2000-04-03 | 256 | 0 |
| K993961 | RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) | American Bio Medica Corp. | 2000-01-24 | 63 | 0 |
| K993151 | RADID DRUG SCREEN 5-PANEL TEST | American Bio Medica Corp. | 2000-01-10 | 111 | 0 |
| K993796 | RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, M | American Bio Medica Corp. | 1999-12-21 | 42 | 0 |
| K992452 | RAPIDONE-AMPHETAMINE TEST | American Bio Medica Corp. | 1999-10-18 | 88 | 0 |
| K990820 | RAPIDONE - OPIATES TEST | American Bio Medica Corp. | 1999-07-15 | 126 | 0 |
| K990822 | RAPIDONE - COCAINE TEST | American Bio Medica Corp. | 1999-07-15 | 126 | 0 |
| K990818 | RAPIDONE - MARIJUANA TEST | American Bio Medica Corp. | 1999-07-07 | 118 | 0 |
| K992033 | MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL | American Bio Medica Corp. | 1999-06-30 | 14 | 0 |
| K984525 | RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST | American Bio Medica Corp. | 1999-02-26 | 67 | 0 |
| K983770 | 'RAPID DRUG SCREEN' 9-PANEL | American Bio Medica Corp. | 1998-12-31 | 66 | 0 |
| K981705 | 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME | American Bio Medica Corp. | 1998-08-27 | 105 | 0 |
| K980872 | RAPID DRUG SCREEN' 8 PANEL | American Bio Medica Corp. | 1998-03-20 | 14 | 0 |
| K964900 | RAPID DRUG SCREEN | American Bio Medica Corp. | 1997-04-14 | 138 | 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