Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Difco Laboratories, Inc. — Predicate Candidate Screening
121 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
105 days90th percentile
121clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971211 | DISPENS-O-DISC SPARFLOXACIN | Difco Laboratories, Inc. | 1997-04-14 | 18 | 0 |
| K971120 | DISPENS-O-DISC (TM) LEVOFLOXACIN | Difco Laboratories, Inc. | 1997-04-14 | 18 | 0 |
| K963508 | DISPENS-O-DISC MEROPENEM | Difco Laboratories, Inc. | 1996-09-26 | 23 | 0 |
| K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | Difco Laboratories, Inc. | 1996-04-26 | 36 | 0 |
| K954783 | DRYSLIDE CARTARRHALIS | Difco Laboratories, Inc. | 1996-02-06 | 112 | 0 |
| K954784 | DRYSIDE NEISSERIA | Difco Laboratories, Inc. | 1996-01-30 | 105 | 0 |
| K953129 | ESP CULTURE SYSTEM - MYCO | Difco Laboratories, Inc. | 1995-12-26 | 173 | 0 |
| K950706 | DRYSLIDE COAGULASE | Difco Laboratories, Inc. | 1995-05-16 | 90 | 0 |
| K944275 | DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. | Difco Laboratories, Inc. | 1994-12-19 | 111 | 0 |
| K941016 | DISPENS-O-DISC(TM) NITROCEFIN | Difco Laboratories, Inc. | 1994-06-30 | 119 | 0 |
| K934894 | CULTURESWAB TRANSPORT SYSTEM | Difco Laboratories, Inc. | 1994-02-22 | 140 | 0 |
| K930702 | DRYSLIDE CEFIN | Difco Laboratories, Inc. | 1993-12-22 | 315 | 0 |
| K930946 | DISPENS-O-DISC CEFPODOXIME 10 MCG. | Difco Laboratories, Inc. | 1993-04-27 | 63 | 0 |
| K930911 | DISPENS-O-DISC CLARITHROMYCIN 15 MG. | Difco Laboratories, Inc. | 1993-04-27 | 64 | 0 |
| K925693 | EZ VIEW | Difco Laboratories, Inc. | 1993-01-15 | 64 | 0 |
| K925747 | DRYSLIDE(TM) INDOLE | Difco Laboratories, Inc. | 1993-01-15 | 63 | 0 |
| K922792 | ZITHROMAX | Difco Laboratories, Inc. | 1992-07-30 | 51 | 0 |
| K922791 | LORACARBEF 30MCG DISK | Difco Laboratories, Inc. | 1992-07-28 | 49 | 0 |
| K922794 | ENOXACIN | Difco Laboratories, Inc. | 1992-07-28 | 49 | 0 |
| K922793 | CEFZIL | Difco Laboratories, Inc. | 1992-07-28 | 49 | 0 |
| K921637 | ESP BLOOD CULTURE SYSTEM | Difco Laboratories, Inc. | 1992-07-14 | 99 | 0 |
| K921583 | DRYSLIDE(TM), PYR | Difco Laboratories, Inc. | 1992-06-19 | 102 | 0 |
| K921282 | MAXAQUIN | Difco Laboratories, Inc. | 1992-05-06 | 50 | 0 |
| K910412 | FLOXIN SUSCEPTIBILITY TEST DISKS | Difco Laboratories, Inc. | 1991-02-27 | 29 | 0 |
| K903968 | TOXO-CUBE | Difco Laboratories, Inc. | 1990-12-18 | 112 | 0 |
| K901784 | DRYSLIDE, BETA-LACTAMASE | Difco Laboratories, Inc. | 1990-06-20 | 64 | 0 |
| K902082 | ZEFAZONE SUSCEPTIBILITY TEST DISKS | Difco Laboratories, Inc. | 1990-06-15 | 38 | 0 |
| K901371 | ASO-CUBE(TM) | Difco Laboratories, Inc. | 1990-05-15 | 53 | 0 |
| K895215 | PASCO MIC/ID GRAM-POSITIVE PANEL | Difco Laboratories, Inc. | 1990-01-29 | 164 | 0 |
| K896398 | DIFCO OXIDASE DRYSLIDE | Difco Laboratories, Inc. | 1989-12-18 | 42 | 1 |
| K894829 | CEFIXIME 5 MCG SENSITIVITY DISKS | Difco Laboratories, Inc. | 1989-09-08 | 39 | 0 |
| K893669 | CELLMATICS SHLAMYDIA DETECTION SYSTEM | Difco Laboratories, Inc. | 1989-06-23 | 39 | 0 |
| K892051 | RUBELLA-CUBE(TM) | Difco Laboratories, Inc. | 1989-06-08 | 71 | 0 |
| K884842 | CMV-CUBE(TM) | Difco Laboratories, Inc. | 1989-04-11 | 141 | 0 |
| K890991 | MONO-CUBE(TM) | Difco Laboratories, Inc. | 1989-03-16 | 17 | 0 |
| K890339 | DIFCO DIRECTOR INOCULATION SYSTEM | Difco Laboratories, Inc. | 1989-02-07 | 15 | 0 |
| K884017 | ROTACUBE | Difco Laboratories, Inc. | 1989-01-24 | 124 | 0 |
| K884761 | MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. | Difco Laboratories, Inc. | 1988-12-05 | 21 | 0 |
| K873829 | CIPRO SENSITIVITY DISKS | Difco Laboratories, Inc. | 1987-10-02 | 11 | 0 |
| K872938 | AMPICIILLIN SULBACTAM 20MCG SENSITIVITY DISKS | Difco Laboratories, Inc. | 1987-08-06 | 10 | 0 |
| K871606 | SPOTTEST FLAGELLA STAIN | Difco Laboratories, Inc. | 1987-05-15 | 21 | 0 |
| K871709 | ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) | Difco Laboratories, Inc. | 1987-05-15 | 14 | 0 |
| K870201 | DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG | Difco Laboratories, Inc. | 1987-04-29 | 99 | 0 |
| K870175 | BROTH ELUTION DISKS CLINDAMYCIN 10MCG | Difco Laboratories, Inc. | 1987-04-29 | 104 | 0 |
| K870854 | BACTO(R) STREP GROUP KIT | Difco Laboratories, Inc. | 1987-04-28 | 56 | 0 |
| K870716 | SPOTTEST 10% SODIUM DESOXYCHOLATE | Difco Laboratories, Inc. | 1987-04-03 | 42 | 0 |
| K870717 | SPOTTEST MICRODASE | Difco Laboratories, Inc. | 1987-04-03 | 42 | 0 |
| K870348 | NORFLOXACIN 10 MCG SENSITIVITY DISKS | Difco Laboratories, Inc. | 1987-03-17 | 48 | 0 |
| K870347 | AZTREONAM 30 MCG SENSITIVITY DISKS | Difco Laboratories, Inc. | 1987-03-05 | 36 | 0 |
| K870449 | SPOTTEST PYR REAGENT | Difco Laboratories, Inc. | 1987-02-26 | 23 | 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