Medical device manufacturer

American Dade

American Dade holds 149 FDA 510(k) clearances across 95 product codes. Median elapsed review time is 42 days. openFDA lists no recall records naming the company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 149
Product codes: 95
Median review: 42 days
Recall records: 0

How does FDA spell American Dade?

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

Which product codes does American Dade file in?

95 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
GGP	Test, Qualitative And Quantitative Factor Deficiency	9	23 days	10 February 1987
JJY	Multi-Analyte Controls, All Kinds (Assayed)	9	55 days	9 July 1987
GIO	Tube, Collection, Capillary Blood	5	18 days	6 November 1981
JPK	Mixture, Hematology Quality Control	5	35 days	9 September 1981
JIT	Calibrator, Secondary	4	56 days	13 April 1984
JIX	Calibrator, Multi-Analyte Mixture	4	50 days	2 September 1987
CIG	Diazo Colorimetry, Bilirubin	3	63 days	13 April 1984
GJS	Test, Time, Prothrombin	3	15 days	13 November 1986
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	3	49 days	31 July 1987
JQW	Station, Pipetting And Diluting, For Clinical Use	3	30 days	25 February 1987
KHQ	Radioassay, Triiodothyronine Uptake	3	66 days	11 April 1986
CDX	Radioimmunoassay, Total Thyroxine	2	7 days	11 February 1986
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	2	24 days	20 October 1987
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	2	44 days	4 April 1984
DIF	Drug Mixture Control Materials	2	40 days	16 May 1984
GGW	Test, Time, Partial Thromboplastin	2	32 days	17 October 1986
JIY	Photometric Method, Iron (Non-Heme)	2	46 days	22 June 1984
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	2	26 days	19 August 1986
JPA	System, Multipurpose For In Vitro Coagulation Studies	2	43 days	12 November 1985
JQP	Calculator/Data Processing Module, For Clinical Use	2	26 days	22 December 1983
JRQ	Shaker/Stirrer	2	18 days	24 November 1981
KSI	Lectins And Protectins	2	64 days	14 April 1982
LAN	Enzyme Immunoassay, N-Acetylprocainamide	2	21 days	6 February 1986
LGP	Assay, Alpha-2-Antiplasmin	2	69 days	17 February 1981
LIB	Device, General Purpose, Microbiology, Diagnostic	2	21 days	25 August 1982

Showing the 25 they file in most, of 95.

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 American Dade 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 American Dade cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K873051	STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY	CGJ	20 October 1987	77
K873171	STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY	JHX	29 September 1987	49
K873052	STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY	CEP	14 September 1987	41
K872789	PARAMAX URINE/CSF CALIBRATOR	JIX	2 September 1987	50
K872195	DATA-FI DIMERTEST LATEX ASSAY	DAP	6 August 1987	59
K872196	AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III	JJS	31 July 1987	53
K871972	STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY	DGE	21 July 1987	61
K871977	DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR	JJY	9 July 1987	48
K872050	PARAMAX CHOLESTEROL REAGENT	LBS	7 July 1987	40
K872360	DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET	GHH	6 July 1987	18

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.