Difco Laboratories, Inc.
Mchenry, IL, US
Difco Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 121 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 121
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 121FDA records hold 121 510(k) clearances for Difco Laboratories, Inc. between 1979 and 1997. The busiest year on record is 1984, with 30. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 3 |
| 1981 | 3 |
| 1982 | 2 |
| 1983 | 5 |
| 1984 | 30 |
| 1985 | 8 |
| 1986 | 19 |
| 1987 | 12 |
| 1988 | 1 |
| 1989 | 8 |
| 1990 | 5 |
| 1991 | 1 |
| 1992 | 7 |
| 1993 | 5 |
| 1994 | 3 |
| 1995 | 2 |
| 1996 | 4 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K971211 | DISPENS-O-DISC SPARFLOXACIN | JTN | Substantially Equivalent | |
| K971120 | DISPENS-O-DISC (TM) LEVOFLOXACIN | JTN | Substantially Equivalent | |
| K963508 | DISPENS-O-DISC MEROPENEM | JTN | Substantially Equivalent | |
| K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | JTW | Substantially Equivalent | |
| K954783 | DRYSLIDE CARTARRHALIS | JTO | Substantially Equivalent | |
| K954784 | DRYSIDE NEISSERIA | LTS | Substantially Equivalent | |
| K953129 | ESP CULTURE SYSTEM - MYCO | MDB | Substantially Equivalent | |
| K950706 | DRYSLIDE COAGULASE | JTL | Substantially Equivalent | |
| K944275 | DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. | JTN | Substantially Equivalent | |
| K941016 | DISPENS-O-DISC(TM) NITROCEFIN | JTO | Substantially Equivalent | |
| K934894 | CULTURESWAB TRANSPORT SYSTEM | JTW | Substantially Equivalent | |
| K930702 | DRYSLIDE CEFIN | JTN | Substantially Equivalent | |
| K930946 | DISPENS-O-DISC CEFPODOXIME 10 MCG. | JTN | Substantially Equivalent | |
| K930911 | DISPENS-O-DISC CLARITHROMYCIN 15 MG. | JTN | Substantially Equivalent | |
| K925747 | DRYSLIDE(TM) INDOLE | JTO | Substantially Equivalent | |
| K925693 | EZ VIEW | MDB | Substantially Equivalent | |
| K922792 | ZITHROMAX | JNT | Substantially Equivalent | |
| K922794 | ENOXACIN | JTN | Substantially Equivalent | |
| K922793 | CEFZIL | JTN | Substantially Equivalent | |
| K922791 | LORACARBEF 30MCG DISK | JTN | Substantially Equivalent | |
| K921637 | ESP BLOOD CULTURE SYSTEM | MDB | Substantially Equivalent | |
| K921583 | DRYSLIDE(TM), PYR | JTO | Substantially Equivalent | |
| K921282 | MAXAQUIN | JTN | Substantially Equivalent | |
| K910412 | FLOXIN SUSCEPTIBILITY TEST DISKS | JTN | Substantially Equivalent | |
| K903968 | TOXO-CUBE | LGD | Substantially Equivalent | |
| K901784 | DRYSLIDE, BETA-LACTAMASE | JTO | Substantially Equivalent | |
| K902082 | ZEFAZONE SUSCEPTIBILITY TEST DISKS | JTN | Substantially Equivalent | |
| K901371 | ASO-CUBE(TM) | GTQ | Substantially Equivalent | |
| K895215 | PASCO MIC/ID GRAM-POSITIVE PANEL | JWY | Substantially Equivalent | |
| K896398 | DIFCO OXIDASE DRYSLIDE | JTO | Substantially Equivalent | |
| K894829 | CEFIXIME 5 MCG SENSITIVITY DISKS | JTN | Substantially Equivalent | |
| K893669 | CELLMATICS SHLAMYDIA DETECTION SYSTEM | LKH | Substantially Equivalent | |
| K892051 | RUBELLA-CUBE(TM) | LFX | Substantially Equivalent | |
| K884842 | CMV-CUBE(TM) | LFZ | Substantially Equivalent | |
| K890991 | MONO-CUBE(TM) | KTN | Substantially Equivalent | |
| K890339 | DIFCO DIRECTOR INOCULATION SYSTEM | LIE | Substantially Equivalent | |
| K884017 | ROTACUBE | LIQ | Substantially Equivalent | |
| K884761 | MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. | GQN | Substantially Equivalent | |
| K873829 | CIPRO SENSITIVITY DISKS | JTN | Substantially Equivalent | |
| K872938 | AMPICIILLIN SULBACTAM 20MCG SENSITIVITY DISKS | JTN | Substantially Equivalent | |
| K871709 | ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) | KZJ | Substantially Equivalent | |
| K871606 | SPOTTEST FLAGELLA STAIN | JTS | Substantially Equivalent | |
| K870201 | DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG | JTN | Substantially Equivalent | |
| K870175 | BROTH ELUTION DISKS CLINDAMYCIN 10MCG | JTN | Substantially Equivalent | |
| K870854 | BACTO(R) STREP GROUP KIT | GTZ | Substantially Equivalent | |
| K870717 | SPOTTEST MICRODASE | JTO | Substantially Equivalent | |
| K870716 | SPOTTEST 10% SODIUM DESOXYCHOLATE | JTO | Substantially Equivalent | |
| K870348 | NORFLOXACIN 10 MCG SENSITIVITY DISKS | JTN | Substantially Equivalent | |
| K870347 | AZTREONAM 30 MCG SENSITIVITY DISKS | JTN | Substantially Equivalent | |
| K870449 | SPOTTEST PYR REAGENT | JTO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GMTAntigens, Ha, Treponema Pallidum
- GTZAntisera, All Groups, Streptococcus Spp.
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- LKHAntisera, Immunoperoxidase, Chlamydia Spp.
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- KIRCells, Animal And Human, Cultured
- JNTChromatographic, Phospholipids
- JSMCulture Media, Non-Propagating Transport
- JSFCulture Media, Single Biochemical Test
- KZJDevice, Gas Generating
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- JWXKit, Screening, Staphylococcus Aureus
- JXAKit, Screening, Urine
- JWYManual Antimicrobial Susceptibility Test Systems
- KFCMethylene Blue, Tissue Stain
- JTLPlasma, Coagulase, Human, Horse And Rabbit
- LIEReagent/Device, Inoculum Calibration
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- LEDStains, Chemical Solution
- JTSStains, Microbiologic
- JTNSusceptibility Test Discs, Antimicrobial
- JTTSusceptibility Test Powders, Antimicrobial
- MDBSystem, Blood Culturing
- DCNSystem, Test, C-Reactive Protein
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- JTWSystem, Transport, Aerobic
- LTSTest Reagents, Neisseria Gonorrhoeae Biochemical
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain