Lancer Specimen Container

FDA 510(k) K812933 · Sherwood Medical Co.

Substantially Equivalent

510(k) numberK812933

Submission

Device name
Lancer Specimen Container
Applicant
Sherwood Medical Co.
Mchenry, IL, US
Received
October 20, 1981
Decision date
November 6, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FMH – Container, Specimen, Sterile
Device class
Class I (low risk)
Regulation
21 CFR 864.3250
Specialty
Pathology

Other 510(k)s with product code FMH

510(k)DeviceApplicantDecision
K900983Tri-Tech Urine Specimen KitFMH · Traditional Tri-Tech, Inc.09/17/1990SE
K823763Various-Specimen CollectorsFMH · Traditional Cordis Corp.01/19/1983SE
K820180Calculi Filter CupFMH · Traditional Omnimedical02/05/1982SE
K802340Specimen SetFMH · Traditional American Pharmaseal Div. Ahsc10/10/1980SE
K802002Urine Specimen Container #'S 1013-1016FMH · Traditional Pollak (Intl.), Ltd.09/09/1980SE
K800947Midstream Collection KitFMH · Traditional Sage Products, Inc.05/30/1980SE
K800309Specimen Collection PanFMH · Traditional Sage Products, Inc.02/26/1980SE
K800233Abco Midstream Urine Collection SetFMH · Traditional Abco Dealers, Inc.02/26/1980SE
K792710Para-Pak Clean VialFMH · Traditional Meridian Diagnostics, Inc.01/28/1980SE
K792156Lancer Specimen ContainerFMH · Traditional Sherwood Medical Co.12/10/1979SE

More from Sherwood Medical Co.

510(k)DeviceDecision
K981365Mahurkar 13.5 FR Cuffed Catheter with Curved ExtensionsMSD · Traditional 11/25/1998SE
K960982Monoject Blunt I.V. Access Cannula/Monoject Hypodermic Syringe with Blunt I.V. Access…FMI · Traditional 12/23/1996SE
K962880Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemCAZ · Traditional 12/09/1996SESK
K960574Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter…FHO · Traditional 08/05/1996SE
K960677Kangaroo Jejunal Feeding SystemKNT · Traditional 05/13/1996SE
K960632Kangaroo Feeding Tube Placment StyletKNT · Traditional 05/09/1996SE
K955831Argyle Aspr-Care Closed Suction SystemBSY · Traditional 03/28/1996SE
K954429Kangaroo Entristar Skin-Level Gastrostomy KitKNT · Traditional 03/08/1996SESK
K954525Sensi-Touch Epidural Anesthesia FilterBXN · Traditional 01/19/1996SE
K950201Argyle(R) Hydrophilic Coated Thoracic CatheterJOL · Traditional 12/15/1995SE

Questions and answers

When was Lancer Specimen Container cleared by the FDA?

Lancer Specimen Container (K812933) received a 510(k) decision of Substantially Equivalent on November 6, 1981, 17 days after the submission was received.

What is the product code of K812933?

The FDA product code is FMH – Container, Specimen, Sterile, a Class I (low risk) device regulated under 21 CFR 864.3250.