Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Laboratory Products Co., Ltd. · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
174 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012576 | CIC-C1Q EIA | American Laboratory Products Co., Ltd. | 2002-01-29 | 173 | 0 |
| K011415 | ALPCO MILENIA ANTI-TG EIA | American Laboratory Products Co., Ltd. | 2001-05-30 | 22 | 0 |
| K011201 | ALPCO MILENIA ANTI-TPO ELISA | American Laboratory Products Co., Ltd. | 2001-05-24 | 35 | 0 |
| K974701 | ORGENTEC ANTI-MPO (P-ANCA) ELISA | American Laboratory Products Co., Ltd. | 1998-02-17 | 71 | 0 |
| K974702 | ORGENTEC ANTI-PR3 (C-ANCA) ELISA | American Laboratory Products Co., Ltd. | 1998-02-17 | 71 | 0 |
| K972190 | THYROGLOBULIN ASSAY SYSTEM | American Laboratory Products Co., Ltd. | 1997-07-14 | 56 | 0 |
| K970932 | ORGENTEC MICRO-ALBUMIN EIA ASSAY | American Laboratory Products Co., Ltd. | 1997-04-08 | 47 | 0 |
| K962057 | ORGENTEC ANTI-RNP/SM ELISA | American Laboratory Products Co., Ltd. | 1996-11-18 | 174 | 0 |
| K962062 | ORGENTEC ANTI-SM ELISA | American Laboratory Products Co., Ltd. | 1996-11-18 | 174 | 0 |
| K962052 | ORGENTEC ABTI-SS-BB(LA) ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | 171 | 0 |
| K962053 | ORGENTEC ANTI-JO-1 ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | 171 | 0 |
| K962054 | ORGENTEC ANTI-SS-A(RO) ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | 171 | 0 |
| K962055 | ORGENTEC ANTI-SCL 70 ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | 171 | 0 |
| K963911 | ALPCO/MERCODIA INSULIN ELISA | American Laboratory Products Co., Ltd. | 1996-11-01 | 32 | 0 |
| K962926 | ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY | American Laboratory Products Co., Ltd. | 1996-10-10 | 73 | 0 |
| K962469 | ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY | American Laboratory Products Co., Ltd. | 1996-09-09 | 76 | 0 |
| K955449 | ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY | American Laboratory Products Co., Ltd. | 1996-05-23 | 176 | 0 |
| K955561 | BUHLMANN VITAMIN B6 REA | American Laboratory Products Co., Ltd. | 1996-05-23 | 169 | 0 |
| K952055 | ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY | American Laboratory Products Co., Ltd. | 1995-07-18 | 77 | 0 |
| K952129 | ORGENTEC ANTI-TPO ELISA | American Laboratory Products Co., Ltd. | 1995-06-20 | 43 | 0 |
| K952130 | ORGENTEC ANTI-TG ELISA | American Laboratory Products Co., Ltd. | 1995-06-20 | 43 | 0 |
| K950217 | ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY) | American Laboratory Products Co., Ltd. | 1995-04-24 | 95 | 0 |
| K950088 | ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) | American Laboratory Products Co., Ltd. | 1995-04-21 | 101 | 0 |
| K950089 | ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY) | American Laboratory Products Co., Ltd. | 1995-04-21 | 101 | 0 |
| K950090 | ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) | American Laboratory Products Co., Ltd. | 1995-04-21 | 101 | 0 |
| K942497 | ANGIOTENSIN CONVERTING ENZYME REA | American Laboratory Products Co., Ltd. | 1994-11-15 | 182 | 0 |
| K913091 | BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY | American Laboratory Products Co., Ltd. | 1991-08-26 | 45 | 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