Gull Laboratories, Inc.

UT, US

Gull Laboratories, Inc. appears in FDA device records in UT. FDA records list 57 510(k) clearances between 1977-06-24 and 1999-02-26, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 57
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

Showing 50 of 57

FDA records hold 57 510(k) clearances for Gull Laboratories, Inc. between 1977 and 1999. The busiest year on record is 1991, with 14. The most recent is 1999, with 1.

Clearances by year, as a table

510(k) clearance decisions for Gull Laboratories, Inc., by decision year
Year	Clearances
1977	4
1982	1
1983	2
1985	1
1988	9
1989	4
1990	7
1991	14
1992	6
1995	6
1997	2
1999	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K983541	HSV 1+2 IGG ELISA TEST	LGC	Substantially Equivalent	1999-02-26
K971857	MUMPS IGG ELISA TESTY	LJY	Substantially Equivalent	1997-11-04
K962343	TOXO IGG ELISA TEST	LGD	Substantially Equivalent	1997-03-24
K935730	EBNA IGG ELISA TEST	LLM	Substantially Equivalent	1995-09-19
K940093	EBV-EA(D) IGG ELISA TEST	LSE	Substantially Equivalent	1995-09-15
K941046	VZV IGG ELISA TEST	LFY	Substantially Equivalent	1995-08-24
K941198	EBV LGG ELISA TEST	LSE	Substantially Equivalent	1995-08-23
K932333	PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR	EFB	Substantially Equivalent	1995-08-15
K941624	RUBELLA IGG ELISA TEST	LFX	Substantially Equivalent	1995-08-04
K922759	HSV-2 IGM ELISA TEST--MODIFICATION	LGC	Substantially Equivalent	1992-10-05
K922758	HSV-1 IGM ELISA TEST -- MODIFICATION	LGC	Substantially Equivalent	1992-10-05
K911233	CHAGAS' IGG ELISA TEST	MIU	Substantially Equivalent	1992-05-04
K915893	RUBELLA IGG ELISA TEST	LFX	Substantially Equivalent	1992-03-04
K915891	TOXO IGG ELISA TEST (MODIFIED)	LGD	Substantially Equivalent	1992-03-04
K915892	CMV IGG ELISA TEST	LFZ	Substantially Equivalent	1992-02-14
K913351	INFLUENZA MAB TEST/INFLUENZA A TEST	GNW	Substantially Equivalent	1991-12-17
K913214	INFLUENZA MAB TEST/INFLUENZA B TEST	GNW	Substantially Equivalent	1991-12-13
K912842	RSV-MAB TEST	LKT	Substantially Equivalent	1991-12-09
K912592	CMV-EA MAB TEST	LIN	Substantially Equivalent	1991-12-04
K912558	GULL ELISAWARE	LIB	Substantially Equivalent	1991-09-16
K911301	VZV IGM TEST	GQX	Substantially Equivalent	1991-07-17
K903013	LYME IGM ELISA TEST	LSR	Substantially Equivalent	1991-06-21
K910955	HSV-1 IGM ELISA TEST	LGC	Substantially Equivalent	1991-05-28
K910954	HSV-1 IGG ELISA TEST	LGC	Substantially Equivalent	1991-05-28
K910953	HSV-2 IGM ELISA TEST	LGC	Substantially Equivalent	1991-05-28
K910952	HSV-2 IGG ELISA TEST	LGC	Substantially Equivalent	1991-05-28
K910872	EBV IGG ELISA TEST	MCD	Substantially Equivalent	1991-04-12
K910042	EBV IGM ELISA TEST	LJN	Substantially Equivalent	1991-02-21
K904083	RUBEOLA IGM ELISA TEST	LJB	Substantially Equivalent	1991-01-03
K903807	CMV IGM ELISA TEST	LFZ	Substantially Equivalent	1990-12-17
K904854	RUBEOLA IGG ELISA TEST	LJB	Substantially Equivalent	1990-12-04
K904084	RUBELLA IGM ELISA TEST	LFX	Substantially Equivalent	1990-12-04
K903324	TOXO IGM ELISA TEST	LGD	Substantially Equivalent	1990-10-16
K901635	RUBELLA IGG ELISA TEST	LFX	Substantially Equivalent	1990-06-28
K900796	CMV IGG ELISA TEST	LFZ	Substantially Equivalent	1990-05-02
K900354	TOXO IGG ELISA TEST	LGD	Substantially Equivalent	1990-04-16
K893230	DETECTADOT TM SYSTEM 2000 CMV IGM TEST	LFZ	Substantially Equivalent	1989-12-18
K893200	DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST	LGD	Substantially Equivalent	1989-12-18
K895891	DETECTADOT SYSTEM 2000 HETEROPHILE TEST	KTN	Substantially Equivalent	1989-10-31
K892202	DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST	LFX	Substantially Equivalent	1989-09-13
K884004	RUBEOLA TEST	GRE	Substantially Equivalent	1988-12-05
K882687	ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST	LKT	Substantially Equivalent	1988-08-30
K875159	DETECTADOT SYSTEM 2000 CMV IGG TEST	GQI	Substantially Equivalent	1988-05-06
K875358	VZV TEST	GQX	Substantially Equivalent	1988-03-31
K880043	EBV-NA TEST	LLM	Substantially Equivalent	1988-03-24
K880007	TOXO IGM TEST	GLZ	Substantially Equivalent	1988-03-17
K875109	DETECTADOT SYSTEM 2000 TOXO IGG TEST	LGD	Substantially Equivalent	1988-03-07
K875254	GULLSORB IGG INACTIVATION REAGENT	DEW	Substantially Equivalent	1988-02-17
K872617	EBV-EA TEST	LSE	Substantially Equivalent	1988-01-05
K853137	CMV TEST	GQI	Substantially Equivalent	1985-11-14

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain