Medical device manufacturer

Syva Co.

Syva Co. holds 448 FDA 510(k) clearances across 109 product codes. Median elapsed review time is 35 days. openFDA lists no recall records naming the company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 448
Product codes: 109
Median review: 35 days
Recall records: 0

How does FDA spell Syva Co.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Syva Co. file in?

109 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
LAS	Drug Specific Control Materials	22	21 days	5 October 1984
DKB	Calibrators, Drug Mixture	21	29 days	21 December 1999
DLJ	Calibrators, Drug Specific	18	23 days	26 December 1990
LDJ	Enzyme Immunoassay, Cannabinoids	17	78 days	18 January 2000
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	14	35 days	18 September 1992
DIF	Drug Mixture Control Materials	13	29 days	3 January 1994
DIS	Enzyme Immunoassay, Barbiturate	13	45 days	22 February 1995
DKZ	Enzyme Immunoassay, Amphetamine	13	23 days	3 August 2001
JXM	Enzyme Immunoassay, Benzodiazepine	13	42 days	27 January 2000
KLT	Enzyme Immunoassay, Carbamazepine	12	24 days	27 January 2000
KLS	Enzyme Immunoassay, Theophylline	11	39 days	27 January 2000
DIP	Enzyme Immunoassay, Diphenylhydantoin	10	27 days	17 May 2001
KXT	Enzyme Immunoassay, Digoxin	10	45 days	1 June 1995
LCM	Enzyme Immunoassay, Phencyclidine	10	38 days	27 January 2000
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	9	46 days	27 January 2000
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	9	83 days	20 March 1987
DJG	Enzyme Immunoassay, Opiates	8	58 days	22 January 1999
DLZ	Enzyme Immunoassay, Phenobarbital	8	42 days	6 June 2001
LAR	Enzyme Immunoassay, Procainamide	8	28 days	24 August 1992
LCD	Enzyme Immunoassay, Gentamicin	8	36 days	18 December 1987
JQP	Calculator/Data Processing Module, For Clinical Use	7	23 days	10 August 1989
KXS	Radioimmunoassay, Methaqualone	7	22 days	27 January 2000
LBZ	Enzyme Immunoassay, Quinidine	7	37 days	24 August 1992
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	7	171 days	30 September 1993
LJP	Antiserum, Fluorescent, Chlamydia Trachomatis	7	75 days	6 August 1987

Showing the 25 they file in most, of 109.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Syva Co. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Syva Co. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K011878	EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL	DKJ	13 August 2001	59
K012257	EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229	DKZ	3 August 2001	16
K011947	EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL	LEG	2 July 2001	11
K011528	EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229	DLZ	6 June 2001	20
K011347	EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229	DIP	17 May 2001	15
K993981	SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL	JXN	1 February 2000	69
K993980	SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL	DML	1 February 2000	69
K993988	SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL	DIO	27 January 2000	64
K993987	SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL	KLT	27 January 2000	64
K993986	SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL	KXS	27 January 2000	64

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.