Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immunostics Co., Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
96 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926569 | IMMUNO RA UNDILUTED | Immunostics Co., Inc. | 1993-04-06 | 96 | 0 |
| K902360 | HEMA-SCREEN | Immunostics Co., Inc. | 1990-07-27 | 59 | 0 |
| K894780 | IMMUNO/ASO | Immunostics Co., Inc. | 1989-10-16 | 81 | 0 |
| K883685 | IMMUNO/FEBRILE ANTIGENS | Immunostics Co., Inc. | 1988-09-28 | 30 | 0 |
| K872910 | IMMUNO/SLE | Immunostics Co., Inc. | 1987-08-12 | 19 | 0 |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Immunostics Co., Inc. | 1986-11-13 | 51 | 0 |
| K854619 | DETECTACULT | Immunostics Co., Inc. | 1986-03-03 | 105 | 0 |
| K853105 | IMMUNO-IM | Immunostics Co., Inc. | 1985-09-03 | 42 | 0 |
| K842110 | SLIDE PREGNANCY TEST | Immunostics Co., Inc. | 1984-07-12 | 44 | 0 |
| K834391 | IMMUNO-RA | Immunostics Co., Inc. | 1984-02-03 | 51 | 0 |
| K834390 | IMMUNO-CRP | Immunostics Co., Inc. | 1984-02-03 | 51 | 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