Product code LIB
- Device name
- Device, General Purpose, Microbiology, Diagnostic
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023677 | OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) | Osmetech | 2003-01-29 |
| K920416 | SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB | Behring Diagnostics, Inc. | 1992-04-08 |
| K912558 | GULL ELISAWARE | Gull Laboratories, Inc. | 1991-09-16 |
| K872273 | CORNING EASY WASH ELISA PLATES | Corning Medical & Scientific | 1987-07-07 |
| K871559 | CELL LIFTER | Corning Costar Corp. | 1987-05-15 |
| K864249 | NORMAL SALINE STERILE | Mds Laboratories, Inc. | 1987-03-31 |
| K863789 | CORNING ELISA PLATES | Corning Medical & Scientific | 1986-10-03 |
| K862112 | MICROSCOPE SLIDES | Abco Dealers, Inc. | 1986-06-13 |
| K854604 | AUTO MASH | Dynatech Corp. | 1985-12-06 |
| K854603 | MULTI MASH 2000 | Dynatech Corp. | 1985-12-06 |
| K854602 | MINI MASH 2000 | Dynatech Corp. | 1985-12-06 |
| K854423 | IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES | Dynatech Laboratories, Inc. | 1985-11-20 |
| K853285 | MYWASHER 5 | Scientific Sales Intl., Inc. | 1985-10-04 |
| K853745 | MIC-CONCEPT VIEWBOX | Microtech Medical Systems, Inc. | 1985-09-19 |
| K850725 | QUADRA TITER MICRO PLATES | Microtech Medical Systems, Inc. | 1985-04-30 |
| K844476 | PORTABLE DIAGNOSTIC LABORATORY | Portable Medical Laboratories, Inc. | 1985-03-13 |
| K844442 | RAPID DIAGNOSTIC KIT | Portable Medical Laboratories, Inc. | 1985-02-01 |
| K844473 | HAND-HELD SLIDE READER | Portable Medical Laboratories, Inc. | 1985-01-04 |
| K843483 | PHARMA-PLAST PETRI DISH | Zimmar Consulting , Ltd. | 1984-09-21 |
| K842052 | GIARDIA GUARD | Gelman Sciences, Inc. | 1984-09-11 |
| K842057 | MACLEAN-FOGG, DISPOS-INOCULA-LOOPS | Polymer Technology Corp. | 1984-06-07 |
| K841632 | CODE-A-WELL SERIES 200 PLATE | Plastic Injectors, Inc. | 1984-05-25 |
| K841937 | CODE-A-WELL SERIES 300 PLATE | Plastic Injectors, Inc. | 1984-05-22 |
| K841390 | CODE-A-WELL | Plastic Injectors, Inc. | 1984-05-02 |
| K833131 | HCC-MYCOBACTERIA STAIN KIT | Dr. C.V. Jacob | 1983-10-27 |
| K831641 | READER MICROELISA SYSTEM | Organon Teknika Corp. | 1983-08-11 |
| K832117 | IMMULON SUBSTRATE REMOVAWELL STRIPS | Dynatech Corp. | 1983-08-08 |
| K831658 | MICROELISA COMP | Organon Teknika Corp. | 1983-07-26 |
| K831643 | STRIPREADER MICROELISA SYSTEM | Organon Teknika Corp. | 1983-07-26 |
| K831642 | HEATING BLOCK MICROELISA SYSTEM | Organon Teknika Corp. | 1983-07-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30197344074390 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
| 30197344074383 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
| 30197344074376 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
| 30197344074369 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
| 09555240404992 | SCU Narrow Cap Sampler | ITL ASIA PACIFIC SDN. BHD. | 2025-06-04 |
| 09555240405593 | SCU Narrow Cap Sampler Syringe Kit | ITL ASIA PACIFIC SDN. BHD. | 2025-04-21 |
| 20193489095040 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-12-25 |
| 00382902461005 | BD Kiestra™ Isolate Suspension Cuvette Array | BECTON, DICKINSON AND COMPANY | 2024-11-19 |
| 20197344029331 | Medline | MEDLINE INDUSTRIES, INC. | 2023-12-11 |
| 20197344003003 | Medline | MEDLINE INDUSTRIES, INC. | 2023-06-08 |
| 00613647022863 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-11-29 |
| 00613647022856 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-11-29 |
| 00810044204636 | Caplugs/Evergreen | CAPlugs | 2021-12-08 |
| 00810044204643 | Caplugs/Evergreen | CAPlugs | 2021-12-08 |
| 00810044204650 | Caplugs/Evergreen | CAPlugs | 2021-12-08 |
| 00810044204629 | Caplugs/Evergreen | CAPlugs | 2021-12-08 |
| 00810044204612 | Caplugs/Evergreen | CAPlugs | 2021-12-08 |
| 00810044204605 | Caplugs/Evergreen | CAPlugs | 2021-12-08 |
| 00810044204599 | Caplugs/Evergreen | CAPlugs | 2021-12-08 |
| 40888277367488 | Medline | MEDLINE INDUSTRIES, INC. | 2021-11-02 |
| 40888277367471 | Medline | MEDLINE INDUSTRIES, INC. | 2021-11-02 |
| 40888277367457 | Medline | MEDLINE INDUSTRIES, INC. | 2021-11-02 |
| 40888277367440 | Medline | MEDLINE INDUSTRIES, INC. | 2021-11-02 |
| 40888277367518 | Medline | MEDLINE INDUSTRIES, INC. | 2021-10-29 |
| 40888277367501 | Medline | MEDLINE INDUSTRIES, INC. | 2021-10-29 |
| 40888277367495 | Medline | MEDLINE INDUSTRIES, INC. | 2021-10-29 |
| 40888277367464 | Medline | MEDLINE INDUSTRIES, INC. | 2021-10-29 |
| 19555240401431 | Safety SubCulture Unit 2 (SCU2) | ITL ASIA PACIFIC SDN. BHD. | 2020-09-19 |
| 19555240401110 | Safety SubCulture Unit (SCU) | ITL ASIA PACIFIC SDN. BHD. | 2020-09-19 |
| 19555240401400 | Transfer Cap Set | ITL ASIA PACIFIC SDN. BHD. | 2020-02-29 |