Biowhittaker Molecular Applications, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K943843 | VARICELISA, MODIFICATION | March 14, 1996 |
| K942361 | WHITSOFT | April 4, 1995 |
| K942250 | BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER | April 4, 1995 |
| K942245 | BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE | April 3, 1995 |
| K925209 | MUMPS STAT | October 14, 1994 |
| K935618 | SPECIMEN TRANSPORT MEDIUM | April 21, 1994 |
| K932679 | RHEUMELISA II HISTONE ANTIBODY TEST KIT | August 23, 1993 |
| K930757 | RHEUMELISA II JO-1 ANTIBODY TEST KIT | March 26, 1993 |
| K930130 | RHEUMELISA II SCL-70 ANTIBODY TEST KIT | March 23, 1993 |
| K920753 | RF STAT IGM TEST KIT | March 30, 1992 |