Medical device manufacturer

Miles Laboratories, Inc.

Miles Laboratories, Inc. holds 158 FDA 510(k) clearances across 96 product codes. Median elapsed review time is 37 days. openFDA lists no recall records naming the company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 158
Product codes: 96
Median review: 37 days
Recall records: 0

How does FDA spell Miles 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 Miles Laboratories, Inc. file in?

96 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
CGA	Glucose Oxidase, Glucose	12	48 days	22 December 1987
JQP	Calculator/Data Processing Module, For Clinical Use	8	30 days	12 August 1986
KQO	Automated Urinalysis System	6	71 days	24 August 1984
CDX	Radioimmunoassay, Total Thyroxine	4	19 days	13 February 1980
IEO	Processor, Tissue, Automated	4	41 days	28 July 1983
KHG	Whole Blood Hemoglobin Determination	4	18 days	30 July 1982
DJB	Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.	3	80 days	29 September 1983
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	3	88 days	8 September 1983
JJW	Urinalysis Controls (Assayed And Unassayed)	3	64 days	8 February 1979
KHQ	Radioassay, Triiodothyronine Uptake	3	31 days	13 February 1980
KLT	Enzyme Immunoassay, Carbamazepine	3	44 days	14 January 1987
LER	Fluorescent Immunoassay, Theophylline	3	21 days	30 June 1983
LET	Fluorescent Immunoassay, Phenobarbital	3	16 days	17 August 1984
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	2	37 days	3 September 1985
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	2	56 days	4 October 1983
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	2	24 days	14 April 1987
CHH	Enzymatic Esterase--Oxidase, Cholesterol	2	19 days	12 August 1981
FPB	Filter, Infusion Line	2	29 days	26 May 1988
JIS	Calibrator, Primary	2	30 days	22 January 1986
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	2	23 days	2 June 1980
JTY	Culture Media, For Isolation Of Pathogenic Neisseria	2	25 days	16 June 1981
KHO	Fluorometer, For Clinical Use	2	31 days	29 November 1982
KLQ	Radioimmunoassay, Amikacin	2	13 days	29 April 1981
KLS	Enzyme Immunoassay, Theophylline	2	17 days	19 March 1984
KNK	Acid, Uric, Uricase (Colorimetric)	2	9 days	10 December 1980

Showing the 25 they file in most, of 96.

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 Miles 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 Miles Laboratories, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K880605	LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER	FPB	26 May 1988	104
K874909	MICRO-BUMINTEST REAGENT TABLETS	JIR	28 April 1988	149
K875079	MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE	CKA	5 April 1988	118
K871835	GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT	CGA	22 December 1987	225
K872120	SERALYZER III BLOOD CHEMISTRY ANALYZER	JJF	28 October 1987	149
K873304	CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)	LJX	11 September 1987	24
K872634	CUTTER PUREFLO PLUS IV FILTER	FPB	4 August 1987	29
K870214	MODIFIED SALTEX REAGENT STRIPS	CHK	29 June 1987	160
K870752	SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS	CFJ	14 April 1987	48
K865053	SERA-TEK MICROSOMAL ANTIBODY TEST	JZO	18 February 1987	56

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.