Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LJG — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
32 daysmedian FDA review time
45 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943228 | MICROSPORIDIUM CONTROL SET | Meridian Diagnostics, Inc. | 1994-10-27 | 113 | 0 |
| K924893 | MICROSPORIDIUM CONTROL SLIDE | Scientific Device Laboratory, Inc. | 1993-01-15 | 109 | 0 |
| K890718 | GRAM STAIN CONTROL SLIDE | Scientific Device Laboratory, Inc. | 1989-03-16 | 31 | 1 |
| K890670 | CRYPTOSPORIDIUM CONTROL SLIDE | Scientific Device Laboratory, Inc. | 1989-03-16 | 35 | 0 |
| K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | Bion Ent., Ltd. | 1989-02-17 | 10 | 0 |
| K883570 | HISTO-CHECK FUNGAL CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 | 45 | 0 |
| K883567 | HISTO-CHECK LEGIONELLA CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 | 45 | 0 |
| K883569 | HISTO-CHECK GRAM NEGATIVE SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 | 45 | 0 |
| K883571 | HISTO-CHECK PARASITIC CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 | 45 | 0 |
| K883568 | HISTO-CHECK ACID FAST SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 | 45 | 0 |
| K883208 | HISTO-CHECK SLIDES | Val Tech Diagnostics, Inc. | 1988-08-25 | 27 | 0 |
| K881106 | ACID FAST BACILLI HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-04-21 | 37 | 0 |
| K881109 | SPIROCHETES HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-04-21 | 37 | 0 |
| K881112 | FUNGI HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-04-21 | 37 | 0 |
| K881108 | PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-04-12 | 28 | 0 |
| K881110 | LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-04-12 | 28 | 0 |
| K881107 | INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-03-30 | 15 | 0 |
| K880962 | ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES | Alpha-Tec Systems, Inc. | 1988-03-30 | 22 | 0 |
| K881111 | INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL | Sigma Diagnostics, Inc. | 1988-03-30 | 15 | 0 |
| K840515 | ACID FAST BACILLI STAIN CONTROL | Scientific Device Laboratory, Inc. | 1984-03-09 | 32 | 0 |
| K840517 | PROTOZOA STAIN CONTROL | Scientific Device Laboratory, Inc. | 1984-03-09 | 32 | 0 |
| K840516 | METACHROMATIC GRANULE STAIN CONTROL | Scientific Device Laboratory, Inc. | 1984-03-09 | 32 | 0 |
| K830134 | Q-CHECK REAGENT STANDARDS | Lab Ability, Inc. | 1983-01-09 | 0 | 0 |
| K823706 | ATS AFB STAIN CONTROL SLIDE | Alpha-Tec Systems, Inc. | 1983-01-07 | 29 | 0 |
| K823704 | ATS GRAM STAIN CONTROL SLIDE | Alpha-Tec Systems, Inc. | 1983-01-07 | 29 | 0 |
| K823705 | ATS PARASITOLOGY STAIN CONTROL SLIDE | Alpha-Tec Systems, Inc. | 1983-01-07 | 29 | 0 |
| K822604 | ACID FAST QUALITY CONTROL SLIDES | Medastat Scientific Corp. | 1982-09-28 | 32 | 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