Company ยท US
Genbio
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2001. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 11, 2001 | K010301 | IMMUNOWELL EA (D) IGG TEST Genbio | LSE |
| Sep 22, 1998 | K974244 | IMMUNODOT MONO-M TEST Genbio | LSE |
| Sep 22, 1998 | K974226 | IMMUNODOT MONO-G TEST Genbio | LSE |
| Aug 10, 1998 | K973941 | IMMUNOWELL EBNA IGG TEST Genbio | LLM |
| Aug 10, 1998 | K973940 | IMMUNOWELL EBV VCA IGG TEST Genbio | LSE |
| Aug 10, 1998 | K973939 | IMMUNOWELL VCA IGM TEST Genbio | LJN |
| May 5, 1997 | K963054 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) Genbio | LJZ |
| May 2, 1997 | K963055 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 Genbio | LJZ |
| May 3, 1996 | K953683 | MMUNO DOT BORRELIA DOT BLOT M TEST Genbio | LSR |
| May 3, 1996 | K953682 | IMMUNO DOT BORRELIA DOT BLOT G TEST Genbio | LSR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||