Medical device manufacturer

Kallestad Laboratories, Inc.

Kallestad Laboratories, Inc. holds 92 FDA 510(k) clearances across 58 product codes. Median elapsed review time is 28 days. openFDA lists no recall records naming the company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 92
Product codes: 58
Median review: 28 days
Recall records: 0

How does FDA spell Kallestad Laboratories, Inc.?

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

Which product codes does Kallestad Laboratories, Inc. file in?

58 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
DGC	Ige, Antigen, Antiserum, Control	8	30 days	10 July 1985
DHB	System, Test, Radioallergosorbent (Rast) Immunological	5	43 days	19 September 1985
DEH	Lambda, Antigen, Antiserum, Control	4	72 days	26 February 1986
CZP	Iga, Antigen, Antiserum, Control	3	28 days	26 February 1986
DFT	Igm, Antigen, Antiserum, Control	3	28 days	28 February 1986
JZS	Electrophoresis Instrumentation	3	8 days	27 April 1977
CDP	Radioimmunoassay, Total Triiodothyronine	2	17 days	2 October 1981
CZQ	Bence-Jones Protein, Antigen, Antiserum, Control	2	14 days	1 September 1981
DBI	Complement C4, Antigen, Antiserum, Control	2	13 days	26 February 1986
DCE	Fab, Antigen, Antiserum, Control	2	11 days	16 February 1979
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	2	16 days	22 July 1982
DDB	Ceruloplasmin, Antigen, Antiserum, Control	2	26 days	16 November 1982
DEW	Igg, Antigen, Antiserum, Control	2	13 days	22 December 1977
DFH	Kappa, Antigen, Antiserum, Control	2	34 days	26 February 1986
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	2	21 days	18 January 1982
LIQ	Enzyme Linked Immunoabsorbent Assay, Rotavirus	2	82 days	22 October 1986
CDD	Radioassay, Vitamin B12	1	84 days	21 March 1977
CDX	Radioimmunoassay, Total Thyroxine	1	14 days	26 July 1976
CEW	Radioimmunoassay, Parathyroid Hormone	1	13 days	22 December 1977
CGN	Acid, Folic, Radioimmunoassay	1	34 days	3 May 1978
CGR	Radioimmunoassay, Cortisol	1	74 days	26 January 1979
CZN	Iga, Fitc, Antigen, Antiserum, Control	1	72 days	26 February 1986
CZX	Hemopexin, Antigen, Antiserum, Control	1	14 days	28 February 1978
DAD	Haptoglobin, Antigen, Antiserum, Control	1	13 days	22 December 1977
DAK	Complement C1q, Antigen, Antiserum, Control	1	28 days	24 June 1977

Showing the 25 they file in most, of 58.

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 Kallestad Laboratories, Inc. 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 Kallestad Laboratories, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K863681	PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM	LJP	3 December 1986	75
K862917	PATHFINDER ROTAVIRUS CHEMILUMINESCENT	LIQ	22 October 1986	82
K863682	PATHFINDER(TM) SPECIMEN COLLECTION KIT	JSM	10 October 1986	21
K862743	PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS	GQG	29 September 1986	70
K862313	KALLESTAD SM/RNP TEST REAGENT	LKJ	6 August 1986	49
K862710	KALLESTAD SSA/SSB ENA TEST REAGENTS	LLL	29 July 1986	13
K855014	QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A	JIX	14 March 1986	88
K855010	QUANTIMETRIC PLUS IGM REAGENT KIT	DFT	28 February 1986	74
K855013	QUANTIMETRIC PLUS SUPPORT PACK	DEH	26 February 1986	72
K855012	QUANTIMETRIC PLUS C4 REAGENT KIT	DBI	26 February 1986	72

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.