Company ยท US
Gull Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1999. Name variants (Inc, Corp, punctuation) are merged.
57510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 7 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 6 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 5 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 4 |
| LSE | Epstein-Barr Virus, Other | 3 |
| GLZ | Antigens, If, Toxoplasma Gondii | 2 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 2 |
| GQI | Antiserum, Cf, Cytomegalovirus | 2 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 2 |
| GQX | Antiserum, Cf, Varicella-Zoster | 2 |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 2 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 2 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 2 |
| DEW | Igg, Antigen, Antiserum, Control | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 1 |
| GRE | Antiserum, Fluorescent, Rubeola | 1 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 26, 1999 | K983541 | HSV 1+2 IGG ELISA TEST Gull Laboratories, Inc. | LGC |
| Nov 4, 1997 | K971857 | MUMPS IGG ELISA TESTY Gull Laboratories, Inc. | LJY |
| Mar 24, 1997 | K962343 | TOXO IGG ELISA TEST Gull Laboratories, Inc. | LGD |
| Sep 19, 1995 | K935730 | EBNA IGG ELISA TEST Gull Laboratories, Inc. | LLM |
| Sep 15, 1995 | K940093 | EBV-EA(D) IGG ELISA TEST Gull Laboratories, Inc. | LSE |
| Aug 24, 1995 | K941046 | VZV IGG ELISA TEST Gull Laboratories, Inc. | LFY |
| Aug 23, 1995 | K941198 | EBV LGG ELISA TEST Gull Laboratories, Inc. | LSE |
| Aug 15, 1995 | K932333 | PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR Gull Laboratories, Inc. | EFB |
| Aug 4, 1995 | K941624 | RUBELLA IGG ELISA TEST Gull Laboratories, Inc. | LFX |
| Oct 5, 1992 | K922759 | HSV-2 IGM ELISA TEST--MODIFICATION Gull Laboratories, Inc. | LGC |
| Oct 5, 1992 | K922758 | HSV-1 IGM ELISA TEST -- MODIFICATION Gull Laboratories, Inc. | LGC |
| May 4, 1992 | K911233 | CHAGAS' IGG ELISA TEST Gull Laboratories, Inc. | MIU |
| Mar 4, 1992 | K915893 | RUBELLA IGG ELISA TEST Gull Laboratories, Inc. | LFX |
| Mar 4, 1992 | K915891 | TOXO IGG ELISA TEST (MODIFIED) Gull Laboratories, Inc. | LGD |
| Feb 14, 1992 | K915892 | CMV IGG ELISA TEST Gull Laboratories, Inc. | LFZ |
| Dec 17, 1991 | K913351 | INFLUENZA MAB TEST/INFLUENZA A TEST Gull Laboratories, Inc. | GNW |
| Dec 13, 1991 | K913214 | INFLUENZA MAB TEST/INFLUENZA B TEST Gull Laboratories, Inc. | GNW |
| Dec 9, 1991 | K912842 | RSV-MAB TEST Gull Laboratories, Inc. | LKT |
| Dec 4, 1991 | K912592 | CMV-EA MAB TEST Gull Laboratories, Inc. | LIN |
| Sep 16, 1991 | K912558 | GULL ELISAWARE Gull Laboratories, Inc. | LIB |
| Jul 17, 1991 | K911301 | VZV IGM TEST Gull Laboratories, Inc. | GQX |
| Jun 21, 1991 | K903013 | LYME IGM ELISA TEST Gull Laboratories, Inc. | LSR |
| May 28, 1991 | K910955 | HSV-1 IGM ELISA TEST Gull Laboratories, Inc. | LGC |
| May 28, 1991 | K910954 | HSV-1 IGG ELISA TEST Gull Laboratories, Inc. | LGC |
| May 28, 1991 | K910953 | HSV-2 IGM ELISA TEST Gull Laboratories, Inc. | LGC |
| May 28, 1991 | K910952 | HSV-2 IGG ELISA TEST Gull Laboratories, Inc. | LGC |
| Apr 12, 1991 | K910872 | EBV IGG ELISA TEST Gull Laboratories, Inc. | MCD |
| Feb 21, 1991 | K910042 | EBV IGM ELISA TEST Gull Laboratories, Inc. | LJN |
| Jan 3, 1991 | K904083 | RUBEOLA IGM ELISA TEST Gull Laboratories, Inc. | LJB |
| Dec 17, 1990 | K903807 | CMV IGM ELISA TEST Gull Laboratories, Inc. | LFZ |
| Dec 4, 1990 | K904854 | RUBEOLA IGG ELISA TEST Gull Laboratories, Inc. | LJB |
| Dec 4, 1990 | K904084 | RUBELLA IGM ELISA TEST Gull Laboratories, Inc. | LFX |
| Oct 16, 1990 | K903324 | TOXO IGM ELISA TEST Gull Laboratories, Inc. | LGD |
| Jun 28, 1990 | K901635 | RUBELLA IGG ELISA TEST Gull Laboratories, Inc. | LFX |
| May 2, 1990 | K900796 | CMV IGG ELISA TEST Gull Laboratories, Inc. | LFZ |
| Apr 16, 1990 | K900354 | TOXO IGG ELISA TEST Gull Laboratories, Inc. | LGD |
| Dec 18, 1989 | K893230 | DETECTADOT TM SYSTEM 2000 CMV IGM TEST Gull Laboratories, Inc. | LFZ |
| Dec 18, 1989 | K893200 | DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST Gull Laboratories, Inc. | LGD |
| Oct 31, 1989 | K895891 | DETECTADOT SYSTEM 2000 HETEROPHILE TEST Gull Laboratories, Inc. | KTN |
| Sep 13, 1989 | K892202 | DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST Gull Laboratories, Inc. | LFX |
| Dec 5, 1988 | K884004 | RUBEOLA TEST Gull Laboratories, Inc. | GRE |
| Aug 30, 1988 | K882687 | ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST Gull Laboratories, Inc. | LKT |
| May 6, 1988 | K875159 | DETECTADOT SYSTEM 2000 CMV IGG TEST Gull Laboratories, Inc. | GQI |
| Mar 31, 1988 | K875358 | VZV TEST Gull Laboratories, Inc. | GQX |
| Mar 24, 1988 | K880043 | EBV-NA TEST Gull Laboratories, Inc. | LLM |
| Mar 17, 1988 | K880007 | TOXO IGM TEST Gull Laboratories, Inc. | GLZ |
| Mar 7, 1988 | K875109 | DETECTADOT SYSTEM 2000 TOXO IGG TEST Gull Laboratories, Inc. | LGD |
| Feb 17, 1988 | K875254 | GULLSORB IGG INACTIVATION REAGENT Gull Laboratories, Inc. | DEW |
| Jan 5, 1988 | K872617 | EBV-EA TEST Gull Laboratories, Inc. | LSE |
| Nov 14, 1985 | K853137 | CMV TEST Gull Laboratories, Inc. | GQI |
Newest 50 of 57.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||