Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

57 results for "Gull Laboratories, Inc."
25–48 of 57
Search insights Median review: 97d Cleared: 100% Top manufacturer: Gull Laboratories, Inc. Lead specialty: Microbiology
Cleared May 28, 1991
HSV-2 IGM ELISA TEST
K910953 · LGC
Gull Laboratories, Inc.
Microbiology · 82d
Cleared May 28, 1991
HSV-2 IGG ELISA TEST
K910952 · LGC
Gull Laboratories, Inc.
Microbiology · 82d
Cleared Apr 12, 1991
EBV IGG ELISA TEST
K910872 · MCD
Gull Laboratories, Inc.
Microbiology · 42d
Cleared Feb 21, 1991
EBV IGM ELISA TEST
K910042 · LJN
Gull Laboratories, Inc.
Microbiology · 48d
Cleared Jan 03, 1991
RUBEOLA IGM ELISA TEST
K904083 · LJB
Gull Laboratories, Inc.
Microbiology · 120d
Cleared Dec 17, 1990
CMV IGM ELISA TEST
K903807 · LFZ
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Dec 04, 1990
RUBEOLA IGG ELISA TEST
K904854 · LJB
Gull Laboratories, Inc.
Microbiology · 36d
Cleared Dec 04, 1990
RUBELLA IGM ELISA TEST
K904084 · LFX
Gull Laboratories, Inc.
Microbiology · 90d
Cleared Oct 16, 1990
TOXO IGM ELISA TEST
K903324 · LGD
Gull Laboratories, Inc.
Microbiology · 83d
Cleared Jun 28, 1990
RUBELLA IGG ELISA TEST
K901635 · LFX
Gull Laboratories, Inc.
Microbiology · 80d
Cleared May 02, 1990
CMV IGG ELISA TEST
K900796 · LFZ
Gull Laboratories, Inc.
Microbiology · 71d
Cleared Apr 16, 1990
TOXO IGG ELISA TEST
K900354 · LGD
Gull Laboratories, Inc.
Microbiology · 81d
Cleared Dec 18, 1989
DETECTADOT TM SYSTEM 2000 CMV IGM TEST
K893230 · LFZ
Gull Laboratories, Inc.
Microbiology · 234d
Cleared Dec 18, 1989
DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST
K893200 · LGD
Gull Laboratories, Inc.
Microbiology · 236d
Cleared Oct 31, 1989
DETECTADOT SYSTEM 2000 HETEROPHILE TEST
K895891 · KTN
Gull Laboratories, Inc.
Immunology · 26d
Cleared Sep 13, 1989
DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST
K892202 · LFX
Gull Laboratories, Inc.
Microbiology · 163d
Cleared Dec 05, 1988
RUBEOLA TEST
K884004 · GRE
Gull Laboratories, Inc.
Microbiology · 75d
Cleared Aug 30, 1988
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
K882687 · LKT
Gull Laboratories, Inc.
Microbiology · 61d
Cleared May 06, 1988
DETECTADOT SYSTEM 2000 CMV IGG TEST
K875159 · GQI
Gull Laboratories, Inc.
Microbiology · 142d
Cleared Mar 31, 1988
VZV TEST
K875358 · GQX
Gull Laboratories, Inc.
Microbiology · 91d
Cleared Mar 24, 1988
EBV-NA TEST
K880043 · LLM
Gull Laboratories, Inc.
Microbiology · 78d
Cleared Mar 17, 1988
TOXO IGM TEST
K880007 · GLZ
Gull Laboratories, Inc.
Microbiology · 73d
Cleared Mar 07, 1988
DETECTADOT SYSTEM 2000 TOXO IGG TEST
K875109 · LGD
Gull Laboratories, Inc.
Microbiology · 84d
Cleared Feb 17, 1988
GULLSORB IGG INACTIVATION REAGENT
K875254 · DEW
Gull Laboratories, Inc.
Immunology · 57d