Pinlock Container

FDA 510(k) K770071 · Perkins Mfg. Co.

Substantially Equivalent

510(k) numberK770071

Submission

Device name
Pinlock Container
Applicant
Perkins Mfg. Co.
Mchenry, IL, US
Received
January 13, 1977
Decision date
February 24, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

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K834579Biospal 2400SKDT · Traditional Hospal Medical Corp.02/04/1984SE
K834412Preserv Pva Fixative 15ML-FORMALIN PKKDT · Traditional Preventive Diagnostics Corp.01/13/1984SE
K833660Preserv Pva Fixative -Malin PackKDT · Traditional Preventive Diagnostics Corp.11/28/1983SE
K823773Provial II #006-010-0201KDT · Traditional Dynatech Corp.01/21/1983SE
K822870Stool-Collection/Preservation KitKDT · Traditional American Scientific Products11/01/1982SE
K821621PregnopostKDT · Traditional M.M. Wolfred, Ph.D.07/21/1982SE
K820246Prefilled Specimen ContainerKDT · Traditional Sage Products, Inc.02/18/1982SE
K811793Fix-Right 90ML & 180 ML Prefilled ContKDT · Traditional Richard-Allan Medical Ind., Inc.07/31/1981SE

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Questions and answers

When was Pinlock Container cleared by the FDA?

Pinlock Container (K770071) received a 510(k) decision of Substantially Equivalent on February 24, 1977, 42 days after the submission was received.

What is the product code of K770071?

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