General Biometrics, Inc.
San Diego, CA, US
General Biometrics, Inc. appears in FDA device records in San Diego, CA. FDA records list 23 510(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
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for General Biometrics, Inc. between 1989 and 1992. The busiest year on record is 1991, with 9. The most recent is 1992, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 6 |
| 1990 | 4 |
| 1991 | 9 |
| 1992 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K924843 | IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL | LLL | Substantially Equivalent | |
| K920401 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST | MID | Substantially Equivalent | |
| K920400 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST | MID | Substantially Equivalent | |
| K911627 | IMMUNODOT BORRELIA (LYME) TEST | LSR | Substantially Equivalent | |
| K911599 | IMMUNOWELL LYME (P39 RECOMBINANT) TEST | LSR | Substantially Equivalent | |
| K911590 | IMMUNOWELL BORRELIA (LYME)TEST | LSR | Substantially Equivalent | |
| K914801 | IMMUNOWELL DSDNA ANTIBODY TEST | DHC | Substantially Equivalent | |
| K911851 | IMMUNOWELL SM ANTIBODY TEST | LKP | Substantially Equivalent | |
| K911850 | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST | LKO | Substantially Equivalent | |
| K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | LKO | Substantially Equivalent | |
| K911848 | IMMUNOWELL RNP/SM ANTIBODY TEST | LKP | Substantially Equivalent | |
| K905485 | IMMUNOWELL THYROGLOBULIN TEST | JZO | Substantially Equivalent | |
| K905486 | IMMUNOWELL TPO (MICROSOME) TEST | JNL | Substantially Equivalent | |
| K903843 | IMMUNODOT THYROID AUTOIMMUNITY PANEL | JNL | Substantially Equivalent | |
| K903047 | IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 | LLL | Substantially Equivalent | |
| K902938 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 | LLL | Substantially Equivalent | |
| K900072 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 | LJM | Substantially Equivalent | |
| K896347 | IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 | LJM | Substantially Equivalent | |
| K894410 | IMMUNODOT LYME TEST | LSR | Substantially Equivalent | |
| K894546 | IMMUNODOT RUBELLA TEST | LFX | Substantially Equivalent | |
| K894975 | IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST | KTN | Substantially Equivalent | |
| K884898 | IMMUNODOT TORCH TEST RUBELLA | LFX | Substantially Equivalent | |
| K885082 | IMMUNODOT RUBELLA TEST | LFX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LLLExtractable Antinuclear Antibody, Antigen And Control
- JNLImmunochemical, Thyroglobulin Autoantibody
- LSRReagent, Borrelia Serological Reagent
- MIDSystem, Test, Anticardiolipin Immunological
- KTNSystem, Test, Infectious Mononucleosis
- DHCSystem, Test, Systemic Lupus Erythematosus
- JZOSystem, Test, Thyroid Autoantibody
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain