Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gull Laboratories, Inc. — Predicate Candidate Screening
57 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
487 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983541 | HSV 1+2 IGG ELISA TEST | Gull Laboratories, Inc. | 1999-02-26 | 140 | 0 |
| K971857 | MUMPS IGG ELISA TESTY | Gull Laboratories, Inc. | 1997-11-04 | 168 | 0 |
| K962343 | TOXO IGG ELISA TEST | Gull Laboratories, Inc. | 1997-03-24 | 279 | 0 |
| K935730 | EBNA IGG ELISA TEST | Gull Laboratories, Inc. | 1995-09-19 | 657 | 0 |
| K940093 | EBV-EA(D) IGG ELISA TEST | Gull Laboratories, Inc. | 1995-09-15 | 616 | 0 |
| K941046 | VZV IGG ELISA TEST | Gull Laboratories, Inc. | 1995-08-24 | 535 | 0 |
| K941198 | EBV LGG ELISA TEST | Gull Laboratories, Inc. | 1995-08-23 | 527 | 0 |
| K932333 | PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR | Gull Laboratories, Inc. | 1995-08-15 | 824 | 0 |
| K941624 | RUBELLA IGG ELISA TEST | Gull Laboratories, Inc. | 1995-08-04 | 487 | 0 |
| K922759 | HSV-2 IGM ELISA TEST--MODIFICATION | Gull Laboratories, Inc. | 1992-10-05 | 119 | 0 |
| K922758 | HSV-1 IGM ELISA TEST -- MODIFICATION | Gull Laboratories, Inc. | 1992-10-05 | 119 | 0 |
| K911233 | CHAGAS' IGG ELISA TEST | Gull Laboratories, Inc. | 1992-05-04 | 411 | 0 |
| K915893 | RUBELLA IGG ELISA TEST | Gull Laboratories, Inc. | 1992-03-04 | 71 | 0 |
| K915891 | TOXO IGG ELISA TEST (MODIFIED) | Gull Laboratories, Inc. | 1992-03-04 | 71 | 0 |
| K915892 | CMV IGG ELISA TEST | Gull Laboratories, Inc. | 1992-02-14 | 52 | 0 |
| K913351 | INFLUENZA MAB TEST/INFLUENZA A TEST | Gull Laboratories, Inc. | 1991-12-17 | 144 | 0 |
| K913214 | INFLUENZA MAB TEST/INFLUENZA B TEST | Gull Laboratories, Inc. | 1991-12-13 | 147 | 0 |
| K912842 | RSV-MAB TEST | Gull Laboratories, Inc. | 1991-12-09 | 166 | 0 |
| K912592 | CMV-EA MAB TEST | Gull Laboratories, Inc. | 1991-12-04 | 177 | 0 |
| K912558 | GULL ELISAWARE | Gull Laboratories, Inc. | 1991-09-16 | 97 | 0 |
| K911301 | VZV IGM TEST | Gull Laboratories, Inc. | 1991-07-17 | 114 | 0 |
| K903013 | LYME IGM ELISA TEST | Gull Laboratories, Inc. | 1991-06-21 | 345 | 0 |
| K910954 | HSV-1 IGG ELISA TEST | Gull Laboratories, Inc. | 1991-05-28 | 83 | 0 |
| K910952 | HSV-2 IGG ELISA TEST | Gull Laboratories, Inc. | 1991-05-28 | 82 | 0 |
| K910953 | HSV-2 IGM ELISA TEST | Gull Laboratories, Inc. | 1991-05-28 | 82 | 0 |
| K910955 | HSV-1 IGM ELISA TEST | Gull Laboratories, Inc. | 1991-05-28 | 83 | 0 |
| K910872 | EBV IGG ELISA TEST | Gull Laboratories, Inc. | 1991-04-12 | 42 | 0 |
| K910042 | EBV IGM ELISA TEST | Gull Laboratories, Inc. | 1991-02-21 | 48 | 0 |
| K904083 | RUBEOLA IGM ELISA TEST | Gull Laboratories, Inc. | 1991-01-03 | 120 | 0 |
| K903807 | CMV IGM ELISA TEST | Gull Laboratories, Inc. | 1990-12-17 | 119 | 0 |
| K904854 | RUBEOLA IGG ELISA TEST | Gull Laboratories, Inc. | 1990-12-04 | 36 | 0 |
| K904084 | RUBELLA IGM ELISA TEST | Gull Laboratories, Inc. | 1990-12-04 | 90 | 0 |
| K903324 | TOXO IGM ELISA TEST | Gull Laboratories, Inc. | 1990-10-16 | 83 | 0 |
| K901635 | RUBELLA IGG ELISA TEST | Gull Laboratories, Inc. | 1990-06-28 | 80 | 0 |
| K900796 | CMV IGG ELISA TEST | Gull Laboratories, Inc. | 1990-05-02 | 71 | 0 |
| K900354 | TOXO IGG ELISA TEST | Gull Laboratories, Inc. | 1990-04-16 | 81 | 0 |
| K893200 | DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST | Gull Laboratories, Inc. | 1989-12-18 | 236 | 0 |
| K893230 | DETECTADOT TM SYSTEM 2000 CMV IGM TEST | Gull Laboratories, Inc. | 1989-12-18 | 234 | 0 |
| K895891 | DETECTADOT SYSTEM 2000 HETEROPHILE TEST | Gull Laboratories, Inc. | 1989-10-31 | 26 | 0 |
| K892202 | DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST | Gull Laboratories, Inc. | 1989-09-13 | 163 | 0 |
| K884004 | RUBEOLA TEST | Gull Laboratories, Inc. | 1988-12-05 | 75 | 0 |
| K882687 | ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST | Gull Laboratories, Inc. | 1988-08-30 | 61 | 0 |
| K875159 | DETECTADOT SYSTEM 2000 CMV IGG TEST | Gull Laboratories, Inc. | 1988-05-06 | 142 | 0 |
| K875358 | VZV TEST | Gull Laboratories, Inc. | 1988-03-31 | 91 | 0 |
| K880043 | EBV-NA TEST | Gull Laboratories, Inc. | 1988-03-24 | 78 | 0 |
| K880007 | TOXO IGM TEST | Gull Laboratories, Inc. | 1988-03-17 | 73 | 0 |
| K875109 | DETECTADOT SYSTEM 2000 TOXO IGG TEST | Gull Laboratories, Inc. | 1988-03-07 | 84 | 0 |
| K875254 | GULLSORB IGG INACTIVATION REAGENT | Gull Laboratories, Inc. | 1988-02-17 | 57 | 0 |
| K872617 | EBV-EA TEST | Gull Laboratories, Inc. | 1988-01-05 | 183 | 0 |
| K853137 | CMV TEST | Gull Laboratories, Inc. | 1985-11-14 | 111 | 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