Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Granite Diagnostics, Inc. — Predicate Candidate Screening
47 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
39 days90th percentile
47clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850970 | BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA | Granite Diagnostics, Inc. | 1985-03-29 | 21 | 0 |
| K850969 | INHIBITORY MOLD AGAR PLATE | Granite Diagnostics, Inc. | 1985-03-29 | 21 | 0 |
| K833254 | STREPTOCOCCUS ID TRIPLATE SYSTEM | Granite Diagnostics, Inc. | 1983-10-28 | 38 | 0 |
| K832365 | TCBS AGAR | Granite Diagnostics, Inc. | 1983-09-01 | 45 | 0 |
| K831349 | STREPTOCOCUS ID PLATE | Granite Diagnostics, Inc. | 1983-05-16 | 21 | 0 |
| K830252 | DIPCHEX DIP-SLIDE CULTURE SYS | Granite Diagnostics, Inc. | 1983-03-07 | 41 | 0 |
| K830251 | CAMPY BLOOD AGAR PLATE | Granite Diagnostics, Inc. | 1983-02-28 | 34 | 0 |
| K823248 | SCHAEDLER AGARS | Granite Diagnostics, Inc. | 1982-12-03 | 32 | 0 |
| K823122 | LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM | Granite Diagnostics, Inc. | 1982-12-03 | 42 | 0 |
| K823139 | SMITH'S MEDIUM | Granite Diagnostics, Inc. | 1982-12-03 | 39 | 0 |
| K822997 | STREP SELECTIVE AGAR | Granite Diagnostics, Inc. | 1982-11-17 | 36 | 0 |
| K822996 | JORDANS TARTRATE AGAR | Granite Diagnostics, Inc. | 1982-11-16 | 35 | 0 |
| K822995 | ANDRADES FERMENTATION MEDIA | Granite Diagnostics, Inc. | 1982-11-16 | 35 | 0 |
| K823001 | PEPTONE IRON AGAR | Granite Diagnostics, Inc. | 1982-11-16 | 35 | 0 |
| K823000 | MACATE BROTH | Granite Diagnostics, Inc. | 1982-11-16 | 35 | 0 |
| K822999 | DNASE TEST AGAR W/TOLUIDINE BLUE | Granite Diagnostics, Inc. | 1982-11-16 | 35 | 0 |
| K822998 | CHRISTENSENS CITRATE SULFIDE AGAR | Granite Diagnostics, Inc. | 1982-11-16 | 35 | 0 |
| K822994 | CORN MEAL AGAR W/POLYSORBATE 80 | Granite Diagnostics, Inc. | 1982-11-16 | 35 | 0 |
| K823072 | LECITHIN LACTOSE AGAR | Granite Diagnostics, Inc. | 1982-11-05 | 17 | 0 |
| K822855 | YERSINIA ISOLATION MEDIUM | Granite Diagnostics, Inc. | 1982-11-05 | 39 | 0 |
| K823070 | ACETAMIDE AGAR SLANT | Granite Diagnostics, Inc. | 1982-11-05 | 17 | 0 |
| K823091 | H BROTH | Granite Diagnostics, Inc. | 1982-11-05 | 17 | 0 |
| K823071 | RICE EXTRACT AGAR | Granite Diagnostics, Inc. | 1982-11-05 | 17 | 0 |
| K822702 | V AGAR | Granite Diagnostics, Inc. | 1982-09-30 | 23 | 0 |
| K822527 | ANAEROBE PEA PLATE | Granite Diagnostics, Inc. | 1982-09-30 | 38 | 0 |
| K822694 | YEAST ASSIMILATION BROTH | Granite Diagnostics, Inc. | 1982-09-30 | 23 | 0 |
| K822558 | LSM AGAR | Granite Diagnostics, Inc. | 1982-09-14 | 21 | 0 |
| K822559 | SXT BLOOD AGAR | Granite Diagnostics, Inc. | 1982-09-14 | 21 | 0 |
| K822377 | HAEMOPHILUS ID PLATE | Granite Diagnostics, Inc. | 1982-08-25 | 19 | 0 |
| K822131 | DERMATOPHYTE TEST MEDIUM | Granite Diagnostics, Inc. | 1982-08-03 | 15 | 0 |
| K821977 | GRAMSTAIN SET | Granite Diagnostics, Inc. | 1982-07-22 | 16 | 0 |
| K821864 | THIOGLYCOLLATE MED. W/VITAMIN K-1 | Granite Diagnostics, Inc. | 1982-07-13 | 19 | 0 |
| K821845 | EGG YOLK AGAR (PLATE) | Granite Diagnostics, Inc. | 1982-07-08 | 16 | 0 |
| K821775 | TERGITOL 7 AGAR WITH TTC | Granite Diagnostics, Inc. | 1982-07-02 | 15 | 0 |
| K821493 | LITTMAN OXGAL AGAR | Granite Diagnostics, Inc. | 1982-06-01 | 14 | 0 |
| K812451 | CAMPY THIOGLYCOLLATE (TUBE) | Granite Diagnostics, Inc. | 1981-09-23 | 26 | 0 |
| K810961 | CAMPYLOBACTER MED. (PLATE) | Granite Diagnostics, Inc. | 1981-05-05 | 26 | 0 |
| K802397 | ANAEROBE BLOOD AGAR | Granite Diagnostics, Inc. | 1980-10-23 | 21 | 0 |
| K790375 | TRYPTIC SOY AGAR W/ 5% HORSE BLOOD | Granite Diagnostics, Inc. | 1979-03-15 | 20 | 0 |
| K780704 | COLUMBIA AGAR WITH 5% RABBIT BLOOD | Granite Diagnostics, Inc. | 1978-05-12 | 17 | 0 |
| K771871 | MARTIN LEWIS AGAR (PLATE) | Granite Diagnostics, Inc. | 1977-10-25 | 21 | 0 |
| K771870 | MARTIN LEWIS AGAR (JEMBEC) | Granite Diagnostics, Inc. | 1977-10-25 | 21 | 0 |
| K771872 | MARTIN LEWIS TRANSGROW | Granite Diagnostics, Inc. | 1977-10-25 | 21 | 0 |
| K771661 | MIDDLEBROOK 7H11 AGAR (PLATE) | Granite Diagnostics, Inc. | 1977-09-12 | 13 | 0 |
| K770874 | IMPROVED THAYER MARTIN (PLATE) | Granite Diagnostics, Inc. | 1977-06-08 | 23 | 0 |
| K770875 | IMPROVED THAYER MARTIN (JEMBEC) | Granite Diagnostics, Inc. | 1977-06-03 | 18 | 0 |
| K770876 | IMPROVED TRANSGROW | Granite Diagnostics, Inc. | 1977-06-03 | 18 | 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