Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immuno-Mycologics, Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
263 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120946 | ALPHA CRYPTOCOCCAL ANTIGEN EIA | Immuno-Mycologics, Inc. | 2012-12-17 | 263 | 0 |
| K112422 | CRAG LATERAL FLOW ASSAY (LFA) | Immuno-Mycologics, Inc. | 2012-03-28 | 218 | 1 |
| K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) | Immuno-Mycologics, Inc. | 2011-07-20 | 342 | 0 |
| K101407 | ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 | Immuno-Mycologics, Inc. | 2011-07-19 | 426 | 0 |
| K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | Immuno-Mycologics, Inc. | 1988-08-25 | 16 | 0 |
| K880029 | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 | Immuno-Mycologics, Inc. | 1988-02-24 | 50 | 0 |
| K843286 | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 | Immuno-Mycologics, Inc. | 1984-10-01 | 41 | 0 |
| K831918 | LA-STAPH IDENTIFICATION SYSTEM | Immuno-Mycologics, Inc. | 1983-06-08 | 0 | 0 |
| K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 | Immuno-Mycologics, Inc. | 1983-05-05 | 50 | 0 |
| K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | Immuno-Mycologics, Inc. | 1981-03-20 | 24 | 0 |
| K802427 | LA-SPORO ANTIBODY SYSTEM | Immuno-Mycologics, Inc. | 1980-10-31 | 25 | 0 |
| K800908 | CAPIK-CANDIDA ALBICANS IDENT. KIT. | Immuno-Mycologics, Inc. | 1980-06-02 | 42 | 0 |
| K791390 | ANTI-BLASTOMYCES SERUM #CF10027X | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791394 | HISTOPLASMA MYCELIAL #CF10020X | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791384 | FUNGAL IMMUNODIFFUSION KIT #ID1001 | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791395 | ANTI-HISTOPLASMA SERUM #CF10025X | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791392 | ANTI-HISTOPLASMA SERUM #CF10026X | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791385 | NEGATIVE CONTROL SERUM FOR CF RO ID | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791382 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791393 | HISTOPLASMA YEAST ANTI #CF10021X | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 1 |
| K791389 | COCCIDIOIDES ANTIGEN #CF10023X | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791387 | ASPERGILLUS MYCELIAL ANTIGEN #CF10024X | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791381 | COCCIDIODES (COCCI) | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791386 | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791383 | CANDIDA IMMUNODIFFUSION KIT #CA1001 | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791388 | ANTI-COCCIDIOIDES SERUM #CF10028X | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 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