Company ยท US
General Biometrics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1992. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 4 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 3 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 3 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 2 |
| LKP | Anti-Sm Antibody, Antigen And Control | 2 |
| MID | System, Test, Anticardiolipin Immunological | 2 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 1, 1992 | K924843 | IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL General Biometrics, Inc. | LLL |
| Aug 20, 1992 | K920401 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST General Biometrics, Inc. | MID |
| Aug 20, 1992 | K920400 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST General Biometrics, Inc. | MID |
| Apr 8, 1992 | K911627 | IMMUNODOT BORRELIA (LYME) TEST General Biometrics, Inc. | LSR |
| Dec 30, 1991 | K911599 | IMMUNOWELL LYME (P39 RECOMBINANT) TEST General Biometrics, Inc. | LSR |
| Dec 20, 1991 | K911590 | IMMUNOWELL BORRELIA (LYME)TEST General Biometrics, Inc. | LSR |
| Dec 9, 1991 | K914801 | IMMUNOWELL DSDNA ANTIBODY TEST General Biometrics, Inc. | DHC |
| May 7, 1991 | K911851 | IMMUNOWELL SM ANTIBODY TEST General Biometrics, Inc. | LKP |
| May 7, 1991 | K911850 | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST General Biometrics, Inc. | LKO |
| May 7, 1991 | K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST General Biometrics, Inc. | LKO |
| May 7, 1991 | K911848 | IMMUNOWELL RNP/SM ANTIBODY TEST General Biometrics, Inc. | LKP |
| Jan 25, 1991 | K905485 | IMMUNOWELL THYROGLOBULIN TEST General Biometrics, Inc. | JZO |
| Jan 3, 1991 | K905486 | IMMUNOWELL TPO (MICROSOME) TEST General Biometrics, Inc. | JNL |
| Oct 2, 1990 | K903843 | IMMUNODOT THYROID AUTOIMMUNITY PANEL General Biometrics, Inc. | JNL |
| Aug 9, 1990 | K903047 | IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 General Biometrics, Inc. | LLL |
| Aug 9, 1990 | K902938 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 General Biometrics, Inc. | LLL |
| Jan 24, 1990 | K900072 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 General Biometrics, Inc. | LJM |
| Dec 5, 1989 | K896347 | IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 General Biometrics, Inc. | LJM |
| Oct 30, 1989 | K894410 | IMMUNODOT LYME TEST General Biometrics, Inc. | LSR |
| Oct 16, 1989 | K894546 | IMMUNODOT RUBELLA TEST General Biometrics, Inc. | LFX |
| Sep 13, 1989 | K894975 | IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST General Biometrics, Inc. | KTN |
| Feb 3, 1989 | K884898 | IMMUNODOT TORCH TEST RUBELLA General Biometrics, Inc. | LFX |
| Feb 2, 1989 | K885082 | IMMUNODOT RUBELLA TEST General Biometrics, Inc. | LFX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||