LIB — Device, General Purpose, Microbiology, Diagnostic Class I
FDA Device Classification
Classification Details
- Product Code
- LIB
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K023677 | osmetech | OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) | January 29, 2003 |
| K920416 | behring diagnostics | SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB | April 8, 1992 |
| K912558 | gull laboratories | GULL ELISAWARE | September 16, 1991 |
| K872273 | corning medical and scientific | CORNING EASY WASH ELISA PLATES | July 7, 1987 |
| K871559 | corning costar | CELL LIFTER | May 15, 1987 |
| K864249 | mds laboratories | NORMAL SALINE STERILE | March 31, 1987 |
| K863789 | corning medical and scientific | CORNING ELISA PLATES | October 3, 1986 |
| K862112 | abco dealers | MICROSCOPE SLIDES | June 13, 1986 |
| K854604 | dynatech | AUTO MASH | December 6, 1985 |
| K854602 | dynatech | MINI MASH 2000 | December 6, 1985 |
| K854603 | dynatech | MULTI MASH 2000 | December 6, 1985 |
| K854423 | dynatech laboratories | IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES | November 20, 1985 |
| K853285 | scientific sales intl | MYWASHER 5 | October 4, 1985 |
| K853745 | microtech medical systems | MIC-CONCEPT VIEWBOX | September 19, 1985 |
| K850725 | microtech medical systems | QUADRA TITER MICRO PLATES | April 30, 1985 |
| K844476 | portable medical laboratories | PORTABLE DIAGNOSTIC LABORATORY | March 13, 1985 |
| K844442 | portable medical laboratories | RAPID DIAGNOSTIC KIT | February 1, 1985 |
| K844473 | portable medical laboratories | HAND-HELD SLIDE READER | January 4, 1985 |
| K843483 | zimmar consulting | PHARMA-PLAST PETRI DISH | September 21, 1984 |
| K842052 | gelman sciences | GIARDIA GUARD | September 11, 1984 |