Company ยท US
Biowhittaker Molecular Applications, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1996. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 3 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 1 |
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 1996 | K943843 | VARICELISA, MODIFICATION Biowhittaker Molecular Applications, Inc. | LFY |
| Apr 4, 1995 | K942361 | WHITSOFT Biowhittaker Molecular Applications, Inc. | JJQ |
| Apr 4, 1995 | K942250 | BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER Biowhittaker Molecular Applications, Inc. | JJQ |
| Apr 3, 1995 | K942245 | BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE Biowhittaker Molecular Applications, Inc. | JJQ |
| Oct 14, 1994 | K925209 | MUMPS STAT Biowhittaker Molecular Applications, Inc. | LJY |
| Apr 21, 1994 | K935618 | SPECIMEN TRANSPORT MEDIUM Biowhittaker Molecular Applications, Inc. | JSM |
| Aug 23, 1993 | K932679 | RHEUMELISA II HISTONE ANTIBODY TEST KIT Biowhittaker Molecular Applications, Inc. | LKJ |
| Mar 26, 1993 | K930757 | RHEUMELISA II JO-1 ANTIBODY TEST KIT Biowhittaker Molecular Applications, Inc. | LLL |
| Mar 23, 1993 | K930130 | RHEUMELISA II SCL-70 ANTIBODY TEST KIT Biowhittaker Molecular Applications, Inc. | LLL |
| Mar 30, 1992 | K920753 | RF STAT IGM TEST KIT Biowhittaker Molecular Applications, Inc. | DHR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||