Penase

FDA 510(k) K833888 · Oxoid U.S.A., Inc.

Substantially Equivalent

510(k) numberK833888

Submission

Device name
Penase
Applicant
Oxoid U.S.A., Inc.
Mchenry, IL, US
Received
November 9, 1983
Decision date
January 3, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
MDB – System, Blood Culturing
Device class
Class I (low risk)
Regulation
21 CFR 866.2560
Specialty
Microbiology

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Questions and answers

When was Penase cleared by the FDA?

Penase (K833888) received a 510(k) decision of Substantially Equivalent on January 3, 1984, 55 days after the submission was received.

What is the product code of K833888?

The FDA product code is MDB – System, Blood Culturing, a Class I (low risk) device regulated under 21 CFR 866.2560.