Company ยท US
Litton Bionetics
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1984. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GLZ | Antigens, If, Toxoplasma Gondii | 3 |
| GOL | Antigen, Ha (Including Ha Control), Rubella | 2 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 2 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 2 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | 2 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 1 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 27, 1984 | K840417 | EBNA ACIF KIT Litton Bionetics | LLM |
| Mar 16, 1984 | K834443 | ROTAVIRUS BIO-ENZABEAD SCREEN KIT Litton Bionetics | LIQ |
| Aug 8, 1983 | K831343 | CMV RQ BIO-ENZABEAD KIT Litton Bionetics | LFZ |
| Dec 3, 1982 | K822985 | EBV-M KIT Litton Bionetics | JRY |
| Sep 14, 1982 | K821804 | RUBELLA RQ BIO-ENZABEAD KIT Litton Bionetics | LFX |
| Sep 16, 1980 | K801722 | CMV BIO-BEAD TITRATION KIT Litton Bionetics | GQH |
| Sep 16, 1980 | K801721 | HSV BIO-BEAD TITRATION KIT Litton Bionetics | GQN |
| Sep 16, 1980 | K801720 | TOXO BIO-BEAD TITRATION KIT Litton Bionetics | GLZ |
| Jun 30, 1980 | K800789 | RUBELLA BIO-BEAD TITRATION KIT Litton Bionetics | GOL |
| Nov 13, 1979 | K791618 | TORCH BIO-BEAD SCREEN KIT Litton Bionetics | GLZ |
| Nov 13, 1979 | K791614 | HSV BIO-BEAD SCREEN KIT Litton Bionetics | GQN |
| Nov 13, 1979 | K791612 | CMV BIO-BEAD SCREEN KIT Litton Bionetics | GQH |
| Nov 13, 1979 | K791611 | TOXO BIO-BEAD SCREEN KIT Litton Bionetics | GLZ |
| Nov 13, 1979 | K791610 | RUBELLA BIO-BEAD SCREEN KIT Litton Bionetics | GOL |
| Jun 22, 1978 | K780925 | EB-VCA, TEST, ANTIBODY, FLUORESCENT Litton Bionetics | JRY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||