Suds(Hcg)Control Set (Urine&Serum) & HCG Ref.Serum

Q: What is the product code of K862048?

The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.

FDA 510(k) K862048 · Murex Corp.

Substantially Equivalent

510(k) numberK862048

Submission

Device name: Suds(Hcg)Control Set (Urine&Serum) & HCG Ref.Serum
Applicant: Murex Corp.
Norcross, GA, US
Received: May 29, 1986
Decision date: June 19, 1986
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DQX – Wire, Guide, Catheter
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1330
Specialty: Cardiovascular

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K253746	Enroute 0.014'' Transcarotid GuidewireDQX · Special	Lake Region Medical	03/19/2026SE
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K253847	Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special	Merit Medical Ireland, Ltd.	01/31/2026SE
K251385	InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional	Merit Medical Ireland, Ltd.	01/21/2026SE
K252674	Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional	Solo Pace, Inc.	01/09/2026SE

More from Solo Pace, Inc.

510(k)	Device	Decision
K861458	Murex Suds ToxoLGD · Traditional	06/13/1986SE
K861282	Murex Suds RubellaLFX · Traditional	06/13/1986SE
K860451	Murex (TM), Suds (TM), HCG AssayLCX · Traditional	04/21/1986SE
K860576	Murex Suds Group a StrepGTZ · Traditional	04/04/1986SE

Questions and answers

When was Suds(Hcg)Control Set (Urine&Serum) & HCG Ref.Serum cleared by the FDA?

Suds(Hcg)Control Set (Urine&Serum) & HCG Ref.Serum (K862048) received a 510(k) decision of Substantially Equivalent on June 19, 1986, 21 days after the submission was received.

What is the product code of K862048?

The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.