Company ยท US
Whittaker Bioproducts, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1992. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LSE | Epstein-Barr Virus, Other | 4 |
| LSR | Reagent, Borrelia Serological Reagent | 4 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 2 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 2 |
| LKQ | Antibody Igm,If, Cytomegalovirus Virus | 2 |
| LYR | Helicobacter Pylori | 2 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 1 |
| GNY | Antisera, Fluorescent, Adenovirus 1-33 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 |
| GRB | Antiserum, Cf, Mumps Virus | 1 |
| GRZ | Antisera, Fluorescent, All, Mycoplasma Spp. | 1 |
| JTC | Device, Microtiter Diluting/Dispensing | 1 |
| JZT | Fluorometer | 1 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 1 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 |
| MJH | Legionella, Spp., Elisa | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 1992 | K911356 | LEGIONELLA STAT IGG/IGM TEST KIT Whittaker Bioproducts, Inc. | MJH |
| Nov 22, 1991 | K913212 | 3M IGE SINGLE POINT FAST TEST Whittaker Bioproducts, Inc. | DHB |
| Oct 21, 1991 | K904652 | LYME STAT M TEST KIT Whittaker Bioproducts, Inc. | LSR |
| Oct 16, 1991 | K904893 | FIAX LYME M TEST KIT Whittaker Bioproducts, Inc. | LSR |
| Sep 25, 1991 | K911473 | EBNA STAT TEST KIT Whittaker Bioproducts, Inc. | LLM |
| May 7, 1991 | K905468 | PYLORI-G FIAX TEST KIT Whittaker Bioproducts, Inc. | LYR |
| May 7, 1991 | K904738 | PYLORI STAT TEST KIT Whittaker Bioproducts, Inc. | LYR |
| Jun 27, 1990 | K901493 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B Whittaker Bioproducts, Inc. | GNX |
| Jan 16, 1990 | K893579 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A Whittaker Bioproducts, Inc. | GNX |
| Oct 16, 1989 | K894932 | FIAX EB VCA-M TEST KIT Whittaker Bioproducts, Inc. | LSE |
| Aug 30, 1989 | K894235 | EB VCA STAT M TEST KIT Whittaker Bioproducts, Inc. | LSE |
| May 10, 1989 | K891086 | STAT TEST KIT FOR EB-VCA IGG ANTIBODY Whittaker Bioproducts, Inc. | LSE |
| Feb 16, 1989 | K885310 | MURINE MONOCLONAL ANTI-ADENOVIRUS IGG Whittaker Bioproducts, Inc. | GNY |
| Jan 13, 1989 | K884516 | FITC MURINE MONOCLONAL ANTI-RSV IGG Whittaker Bioproducts, Inc. | GQG |
| Oct 6, 1988 | K883352 | FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI Whittaker Bioproducts, Inc. | LJP |
| Aug 3, 1988 | K882024 | FITC MURINE MONOCLONAL ANTI-CMV IGG Whittaker Bioproducts, Inc. | GQH |
| Aug 3, 1988 | K882023 | FIAX TEST KIT FOR EB-VCA-G ANTIBODY Whittaker Bioproducts, Inc. | LSE |
| May 13, 1988 | K881180 | FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG Whittaker Bioproducts, Inc. | GQN |
| May 13, 1988 | K880996 | FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG Whittaker Bioproducts, Inc. | GQN |
| Apr 12, 1988 | K875113 | TOXOSTAT M TEST KIT Whittaker Bioproducts, Inc. | LGD |
| Mar 30, 1988 | K875286 | LYME STAT TEST KIT Whittaker Bioproducts, Inc. | LSR |
| Nov 25, 1987 | K873708 | FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES Whittaker Bioproducts, Inc. | LLL |
| Oct 15, 1987 | K872247 | FIAX TEST KIT FOR LYME DISEASE ANTIBODIES Whittaker Bioproducts, Inc. | LSR |
| Oct 6, 1987 | K872733 | FIAX TEST KIT FOR MUMPS-G ANTIBODIES Whittaker Bioproducts, Inc. | GRB |
| Apr 14, 1987 | K863798 | FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES Whittaker Bioproducts, Inc. | LKQ |
| Oct 29, 1986 | K863434 | THE FIAX 5000 FLUOROMETER Whittaker Bioproducts, Inc. | JZT |
| Aug 8, 1986 | K861716 | FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY Whittaker Bioproducts, Inc. | GRZ |
| Feb 4, 1986 | K854839 | CYTOMEGELISA M TEST KIT Whittaker Bioproducts, Inc. | LKQ |
| Jan 30, 1985 | K844552 | BIO-STAT III PLATE WASHER Whittaker Bioproducts, Inc. | JTC |
| Nov 1, 1984 | K843904 | DNA STAT TEST KIT Whittaker Bioproducts, Inc. | LJM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||