Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
General Biometrics, Inc. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
255 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924843 | IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL | General Biometrics, Inc. | 1992-12-01 | 64 | 0 |
| K920401 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST | General Biometrics, Inc. | 1992-08-20 | 204 | 0 |
| K920400 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST | General Biometrics, Inc. | 1992-08-20 | 204 | 0 |
| K911627 | IMMUNODOT BORRELIA (LYME) TEST | General Biometrics, Inc. | 1992-04-08 | 363 | 0 |
| K911599 | IMMUNOWELL LYME (P39 RECOMBINANT) TEST | General Biometrics, Inc. | 1991-12-30 | 265 | 0 |
| K911590 | IMMUNOWELL BORRELIA (LYME)TEST | General Biometrics, Inc. | 1991-12-20 | 255 | 1 |
| K914801 | IMMUNOWELL DSDNA ANTIBODY TEST | General Biometrics, Inc. | 1991-12-09 | 46 | 0 |
| K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 | 11 | 0 |
| K911851 | IMMUNOWELL SM ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 | 11 | 0 |
| K911850 | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 | 11 | 0 |
| K911848 | IMMUNOWELL RNP/SM ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 | 11 | 0 |
| K905485 | IMMUNOWELL THYROGLOBULIN TEST | General Biometrics, Inc. | 1991-01-25 | 50 | 0 |
| K905486 | IMMUNOWELL TPO (MICROSOME) TEST | General Biometrics, Inc. | 1991-01-03 | 28 | 0 |
| K903843 | IMMUNODOT THYROID AUTOIMMUNITY PANEL | General Biometrics, Inc. | 1990-10-02 | 42 | 0 |
| K902938 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 | General Biometrics, Inc. | 1990-08-09 | 37 | 0 |
| K903047 | IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 | General Biometrics, Inc. | 1990-08-09 | 29 | 0 |
| K900072 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 | General Biometrics, Inc. | 1990-01-24 | 19 | 0 |
| K896347 | IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 | General Biometrics, Inc. | 1989-12-05 | 32 | 0 |
| K894410 | IMMUNODOT LYME TEST | General Biometrics, Inc. | 1989-10-30 | 105 | 0 |
| K894546 | IMMUNODOT RUBELLA TEST | General Biometrics, Inc. | 1989-10-16 | 87 | 0 |
| K894975 | IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST | General Biometrics, Inc. | 1989-09-13 | 37 | 0 |
| K884898 | IMMUNODOT TORCH TEST RUBELLA | General Biometrics, Inc. | 1989-02-03 | 72 | 0 |
| K885082 | IMMUNODOT RUBELLA TEST | General Biometrics, Inc. | 1989-02-02 | 55 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda