Biowhittaker Molecular Applications, Inc.
Walkersville, MD, US
Biowhittaker Molecular Applications, Inc. appears in FDA device records in Walkersville, MD. FDA records list 10 510(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
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Biowhittaker Molecular Applications, Inc. between 1992 and 1996. The busiest year on record is 1993, with 3. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 2 |
| 1995 | 3 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K943843 | VARICELISA, MODIFICATION | LFY | Substantially Equivalent | |
| K942361 | WHITSOFT | JJQ | Substantially Equivalent | |
| K942250 | BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER | JJQ | Substantially Equivalent | |
| K942245 | BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE | JJQ | Substantially Equivalent | |
| K925209 | MUMPS STAT | LJY | Substantially Equivalent | |
| K935618 | SPECIMEN TRANSPORT MEDIUM | JSM | Substantially Equivalent | |
| K932679 | RHEUMELISA II HISTONE ANTIBODY TEST KIT | LKJ | Substantially Equivalent | |
| K930757 | RHEUMELISA II JO-1 ANTIBODY TEST KIT | LLL | Substantially Equivalent | |
| K930130 | RHEUMELISA II SCL-70 ANTIBODY TEST KIT | LLL | Substantially Equivalent | |
| K920753 | RF STAT IGM TEST KIT | DHR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LKJAntinuclear Antibody, Antigen, Control
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JSMCulture Media, Non-Propagating Transport
- LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- LLLExtractable Antinuclear Antibody, Antigen And Control
- DHRSystem, Test, Rheumatoid Factor
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