Company ยท US
Difco Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1997. Name variants (Inc, Corp, punctuation) are merged.
121510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 41 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 34 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 |
| JSF | Culture Media, Single Biochemical Test | 3 |
| JTW | System, Transport, Aerobic | 3 |
| KIR | Cells, Animal And Human, Cultured | 3 |
| MDB | System, Blood Culturing | 3 |
| LED | Stains, Chemical Solution | 2 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| GMT | Antigens, Ha, Treponema Pallidum | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 |
| JNT | Chromatographic, Phospholipids | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 1 |
| JTS | Stains, Microbiologic | 1 |
| JTT | Susceptibility Test Powders, Antimicrobial | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 1997 | K971211 | DISPENS-O-DISC SPARFLOXACIN Difco Laboratories, Inc. | JTN |
| Apr 14, 1997 | K971120 | DISPENS-O-DISC (TM) LEVOFLOXACIN Difco Laboratories, Inc. | JTN |
| Sep 26, 1996 | K963508 | DISPENS-O-DISC MEROPENEM Difco Laboratories, Inc. | JTN |
| Apr 26, 1996 | K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) Difco Laboratories, Inc. | JTW |
| Feb 6, 1996 | K954783 | DRYSLIDE CARTARRHALIS Difco Laboratories, Inc. | JTO |
| Jan 30, 1996 | K954784 | DRYSIDE NEISSERIA Difco Laboratories, Inc. | LTS |
| Dec 26, 1995 | K953129 | ESP CULTURE SYSTEM - MYCO Difco Laboratories, Inc. | MDB |
| May 16, 1995 | K950706 | DRYSLIDE COAGULASE Difco Laboratories, Inc. | JTL |
| Dec 19, 1994 | K944275 | DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. Difco Laboratories, Inc. | JTN |
| Jun 30, 1994 | K941016 | DISPENS-O-DISC(TM) NITROCEFIN Difco Laboratories, Inc. | JTO |
| Feb 22, 1994 | K934894 | CULTURESWAB TRANSPORT SYSTEM Difco Laboratories, Inc. | JTW |
| Dec 22, 1993 | K930702 | DRYSLIDE CEFIN Difco Laboratories, Inc. | JTN |
| Apr 27, 1993 | K930946 | DISPENS-O-DISC CEFPODOXIME 10 MCG. Difco Laboratories, Inc. | JTN |
| Apr 27, 1993 | K930911 | DISPENS-O-DISC CLARITHROMYCIN 15 MG. Difco Laboratories, Inc. | JTN |
| Jan 15, 1993 | K925747 | DRYSLIDE(TM) INDOLE Difco Laboratories, Inc. | JTO |
| Jan 15, 1993 | K925693 | EZ VIEW Difco Laboratories, Inc. | MDB |
| Jul 30, 1992 | K922792 | ZITHROMAX Difco Laboratories, Inc. | JNT |
| Jul 28, 1992 | K922794 | ENOXACIN Difco Laboratories, Inc. | JTN |
| Jul 28, 1992 | K922793 | CEFZIL Difco Laboratories, Inc. | JTN |
| Jul 28, 1992 | K922791 | LORACARBEF 30MCG DISK Difco Laboratories, Inc. | JTN |
| Jul 14, 1992 | K921637 | ESP BLOOD CULTURE SYSTEM Difco Laboratories, Inc. | MDB |
| Jun 19, 1992 | K921583 | DRYSLIDE(TM), PYR Difco Laboratories, Inc. | JTO |
| May 6, 1992 | K921282 | MAXAQUIN Difco Laboratories, Inc. | JTN |
| Feb 27, 1991 | K910412 | FLOXIN SUSCEPTIBILITY TEST DISKS Difco Laboratories, Inc. | JTN |
| Dec 18, 1990 | K903968 | TOXO-CUBE Difco Laboratories, Inc. | LGD |
| Jun 20, 1990 | K901784 | DRYSLIDE, BETA-LACTAMASE Difco Laboratories, Inc. | JTO |
| Jun 15, 1990 | K902082 | ZEFAZONE SUSCEPTIBILITY TEST DISKS Difco Laboratories, Inc. | JTN |
| May 15, 1990 | K901371 | ASO-CUBE(TM) Difco Laboratories, Inc. | GTQ |
| Jan 29, 1990 | K895215 | PASCO MIC/ID GRAM-POSITIVE PANEL Difco Laboratories, Inc. | JWY |
| Dec 18, 1989 | K896398 | DIFCO OXIDASE DRYSLIDE Difco Laboratories, Inc. | JTO |
| Sep 8, 1989 | K894829 | CEFIXIME 5 MCG SENSITIVITY DISKS Difco Laboratories, Inc. | JTN |
| Jun 23, 1989 | K893669 | CELLMATICS SHLAMYDIA DETECTION SYSTEM Difco Laboratories, Inc. | LKH |
| Jun 8, 1989 | K892051 | RUBELLA-CUBE(TM) Difco Laboratories, Inc. | LFX |
| Apr 11, 1989 | K884842 | CMV-CUBE(TM) Difco Laboratories, Inc. | LFZ |
| Mar 16, 1989 | K890991 | MONO-CUBE(TM) Difco Laboratories, Inc. | KTN |
| Feb 7, 1989 | K890339 | DIFCO DIRECTOR INOCULATION SYSTEM Difco Laboratories, Inc. | LIE |
| Jan 24, 1989 | K884017 | ROTACUBE Difco Laboratories, Inc. | LIQ |
| Dec 5, 1988 | K884761 | MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. Difco Laboratories, Inc. | GQN |
| Oct 2, 1987 | K873829 | CIPRO SENSITIVITY DISKS Difco Laboratories, Inc. | JTN |
| Aug 6, 1987 | K872938 | AMPICIILLIN SULBACTAM 20MCG SENSITIVITY DISKS Difco Laboratories, Inc. | JTN |
| May 15, 1987 | K871709 | ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) Difco Laboratories, Inc. | KZJ |
| May 15, 1987 | K871606 | SPOTTEST FLAGELLA STAIN Difco Laboratories, Inc. | JTS |
| Apr 29, 1987 | K870201 | DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG Difco Laboratories, Inc. | JTN |
| Apr 29, 1987 | K870175 | BROTH ELUTION DISKS CLINDAMYCIN 10MCG Difco Laboratories, Inc. | JTN |
| Apr 28, 1987 | K870854 | BACTO(R) STREP GROUP KIT Difco Laboratories, Inc. | GTZ |
| Apr 3, 1987 | K870717 | SPOTTEST MICRODASE Difco Laboratories, Inc. | JTO |
| Apr 3, 1987 | K870716 | SPOTTEST 10% SODIUM DESOXYCHOLATE Difco Laboratories, Inc. | JTO |
| Mar 17, 1987 | K870348 | NORFLOXACIN 10 MCG SENSITIVITY DISKS Difco Laboratories, Inc. | JTN |
| Mar 5, 1987 | K870347 | AZTREONAM 30 MCG SENSITIVITY DISKS Difco Laboratories, Inc. | JTN |
| Feb 26, 1987 | K870449 | SPOTTEST PYR REAGENT Difco Laboratories, Inc. | JTO |
Newest 50 of 121.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||