Whittaker Bioproducts, Inc.
Walkersville, MD, US
Whittaker Bioproducts, Inc. appears in FDA device records in Walkersville, MD. FDA records list 30 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 30
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 30 510(k) clearances for Whittaker Bioproducts, Inc. between 1984 and 1992. The busiest year on record is 1988, with 7. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 4 |
| 1988 | 7 |
| 1989 | 5 |
| 1990 | 2 |
| 1991 | 6 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K911356 | LEGIONELLA STAT IGG/IGM TEST KIT | MJH | Substantially Equivalent | |
| K913212 | 3M IGE SINGLE POINT FAST TEST | DHB | Substantially Equivalent | |
| K904652 | LYME STAT M TEST KIT | LSR | Substantially Equivalent | |
| K904893 | FIAX LYME M TEST KIT | LSR | Substantially Equivalent | |
| K911473 | EBNA STAT TEST KIT | LLM | Substantially Equivalent | |
| K905468 | PYLORI-G FIAX TEST KIT | LYR | Substantially Equivalent | |
| K904738 | PYLORI STAT TEST KIT | LYR | Substantially Equivalent | |
| K901493 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B | GNX | Substantially Equivalent | |
| K893579 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A | GNX | Substantially Equivalent | |
| K894932 | FIAX EB VCA-M TEST KIT | LSE | Substantially Equivalent | |
| K894235 | EB VCA STAT M TEST KIT | LSE | Substantially Equivalent | |
| K891086 | STAT TEST KIT FOR EB-VCA IGG ANTIBODY | LSE | Substantially Equivalent | |
| K885310 | MURINE MONOCLONAL ANTI-ADENOVIRUS IGG | GNY | Substantially Equivalent | |
| K884516 | FITC MURINE MONOCLONAL ANTI-RSV IGG | GQG | Substantially Equivalent | |
| K883352 | FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI | LJP | Substantially Equivalent | |
| K882024 | FITC MURINE MONOCLONAL ANTI-CMV IGG | GQH | Substantially Equivalent | |
| K882023 | FIAX TEST KIT FOR EB-VCA-G ANTIBODY | LSE | Substantially Equivalent | |
| K881180 | FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG | GQN | Substantially Equivalent | |
| K880996 | FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG | GQN | Substantially Equivalent | |
| K875113 | TOXOSTAT M TEST KIT | LGD | Substantially Equivalent | |
| K875286 | LYME STAT TEST KIT | LSR | Substantially Equivalent | |
| K873708 | FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES | LLL | Substantially Equivalent | |
| K872247 | FIAX TEST KIT FOR LYME DISEASE ANTIBODIES | LSR | Substantially Equivalent | |
| K872733 | FIAX TEST KIT FOR MUMPS-G ANTIBODIES | GRB | Substantially Equivalent | |
| K863798 | FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES | LKQ | Substantially Equivalent | |
| K863434 | THE FIAX 5000 FLUOROMETER | JZT | Substantially Equivalent | |
| K861716 | FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY | GRZ | Substantially Equivalent | |
| K854839 | CYTOMEGELISA M TEST KIT | LKQ | Substantially Equivalent | |
| K844552 | BIO-STAT III PLATE WASHER | JTC | Substantially Equivalent | |
| K843904 | DNA STAT TEST KIT | LJM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LKQAntibody Igm,If, Cytomegalovirus Virus
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- GNYAntisera, Fluorescent, Adenovirus 1-33
- GRZAntisera, Fluorescent, All, Mycoplasma Spp.
- GRBAntiserum, Cf, Mumps Virus
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- JTCDevice, Microtiter Diluting/Dispensing
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LSEEpstein-Barr Virus, Other
- LLLExtractable Antinuclear Antibody, Antigen And Control
- JZTFluorometer
- LYRHelicobacter Pylori
- MJHLegionella, Spp., Elisa
- LSRReagent, Borrelia Serological Reagent
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain