Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Atlantic Antibodies · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
47 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892526 | SPQ TM TEST SYSTEM II FOR CRP | Atlantic Antibodies | 1989-05-09 | 28 | 0 |
| K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B | Atlantic Antibodies | 1989-03-16 | 10 | 0 |
| K890563 | SPQ(TM) ANTIBODY REAGENT SET II FOR TRF | Atlantic Antibodies | 1989-03-03 | 38 | 0 |
| K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | Atlantic Antibodies | 1989-02-23 | 30 | 0 |
| K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG | Atlantic Antibodies | 1989-02-22 | 29 | 0 |
| K890562 | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | Atlantic Antibodies | 1989-02-22 | 29 | 0 |
| K890417 | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | Atlantic Antibodies | 1989-02-17 | 24 | 0 |
| K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | Atlantic Antibodies | 1989-02-17 | 24 | 0 |
| K890564 | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | Atlantic Antibodies | 1989-02-17 | 24 | 0 |
| K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | Atlantic Antibodies | 1989-02-15 | 22 | 0 |
| K884298 | SPQ(TM) TEST SYSTEM FOR MICROALBUMIN | Atlantic Antibodies | 1988-11-02 | 21 | 0 |
| K884297 | SPQ(TM) TEST SYSTEM FOR PREALBUMIN | Atlantic Antibodies | 1988-11-02 | 21 | 0 |
| K881898 | MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B | Atlantic Antibodies | 1988-06-14 | 47 | 0 |
| K870564 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B | Atlantic Antibodies | 1987-03-24 | 42 | 0 |
| K870862 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL | Atlantic Antibodies | 1987-03-24 | 21 | 0 |
| K861167 | IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST | Atlantic Antibodies | 1986-04-25 | 28 | 0 |
| K851842 | SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN | Atlantic Antibodies | 1985-06-05 | 40 | 0 |
| K833119 | AUTOIMMUNE TEST 1/2/3 SYSTEM | Atlantic Antibodies | 1983-11-21 | 69 | 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