Litton Bionetics
Mchenry, IL, US
Litton Bionetics appears in FDA device records in Mchenry, IL. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Litton Bionetics between 1978 and 1984. The busiest year on record is 1979, with 5. The most recent is 1984, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 5 |
| 1980 | 4 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K840417 | EBNA ACIF KIT | LLM | Substantially Equivalent | |
| K834443 | ROTAVIRUS BIO-ENZABEAD SCREEN KIT | LIQ | Substantially Equivalent | |
| K831343 | CMV RQ BIO-ENZABEAD KIT | LFZ | Substantially Equivalent | |
| K822985 | EBV-M KIT | JRY | Substantially Equivalent | |
| K821804 | RUBELLA RQ BIO-ENZABEAD KIT | LFX | Substantially Equivalent | |
| K801722 | CMV BIO-BEAD TITRATION KIT | GQH | Substantially Equivalent | |
| K801721 | HSV BIO-BEAD TITRATION KIT | GQN | Substantially Equivalent | |
| K801720 | TOXO BIO-BEAD TITRATION KIT | GLZ | Substantially Equivalent | |
| K800789 | RUBELLA BIO-BEAD TITRATION KIT | GOL | Substantially Equivalent | |
| K791618 | TORCH BIO-BEAD SCREEN KIT | GLZ | Substantially Equivalent | |
| K791614 | HSV BIO-BEAD SCREEN KIT | GQN | Substantially Equivalent | |
| K791612 | CMV BIO-BEAD SCREEN KIT | GQH | Substantially Equivalent | |
| K791611 | TOXO BIO-BEAD SCREEN KIT | GLZ | Substantially Equivalent | |
| K791610 | RUBELLA BIO-BEAD SCREEN KIT | GOL | Substantially Equivalent | |
| K780925 | EB-VCA, TEST, ANTIBODY, FLUORESCENT | JRY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GOLAntigen, Ha (Including Ha Control), Rubella
- GLZAntigens, If, Toxoplasma Gondii
- JRYAntiserum, Fluorescent, Epstein-Barr Virus
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- 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