Granbio, Inc.
Temecula, CA, US
Granbio, Inc. appears in FDA device records in Temecula, CA. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Granbio, Inc. between 1987 and 1996. The busiest year on record is 1987, with 3. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 3 |
| 1988 | 1 |
| 1990 | 2 |
| 1994 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K951822 | EBNA ENZYME IMMUNOASSAY KIT | LLM | Substantially Equivalent | |
| K934774 | UNKNOWN | LSE | Substantially Equivalent | |
| K901840 | (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM | LJN | Substantially Equivalent | |
| K901156 | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM | GNP | Substantially Equivalent | |
| K881617 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY | LSE | Substantially Equivalent | |
| K871298 | EBNA ACIF ASSAY KIT | LLM | Substantially Equivalent | |
| K864604 | EBV VCA IGM ANTIBODY ASSAY KIT | LJN | Substantially Equivalent | |
| K864347 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | GNP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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