Helix Diagnostics, Inc.

West Sacramento, CA, US

Helix Diagnostics, Inc. appears in FDA device records in West Sacramento, CA. FDA records list 15 510(k) clearances between 1991-11-05 and 2000-09-11, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 15
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 15 510(k) clearances for Helix Diagnostics, Inc. between 1991 and 2000. The busiest year on record is 1995, with 5. The most recent is 2000, with 2.

Clearances by year, as a table

510(k) clearance decisions for Helix Diagnostics, Inc., by decision year
Year	Clearances
1991	1
1993	3
1994	2
1995	5
1996	1
1998	1
2000	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K001900	ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST	LRM	Substantially Equivalent	2000-09-11
K000489	ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST	LLL	Substantially Equivalent	2000-04-05
K980337	DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM	LJM	Substantially Equivalent	1998-05-12
K960091	ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT	LRM	Substantially Equivalent	1996-03-20
K954723	ENZYME IMMUNOASSAY ANA SCREENING TEST KIT	LKJ	Substantially Equivalent	1995-12-15
K954700	ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT	LKJ	Substantially Equivalent	1995-12-15
K952253	ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT	LLL	Substantially Equivalent	1995-08-24
K951850	ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT	LJM	Substantially Equivalent	1995-07-18
K951798	ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT	LJM	Substantially Equivalent	1995-07-17
K940588	ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT	LKO	Substantially Equivalent	1994-04-20
K940510	ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT	LKP	Substantially Equivalent	1994-04-20
K932850	ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN	LLL	Substantially Equivalent	1993-09-24
K932419	ANTI-SS-B/LA ANTIBODY TEST	LLL	Substantially Equivalent	1993-08-05
K931495	ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT	LLL	Substantially Equivalent	1993-07-16
K913041	ANTI-DSDNA ANTIBODY TEST	LLL	Substantially Equivalent	1991-11-05

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.

Verification record

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What MDM checks, and what it does not

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