Transtube MW176 Ot MD176

FDA 510(k) K872213 · Medical Wire & Equipment Co.

Substantially Equivalent

510(k) numberK872213

Submission

Device name
Transtube MW176 Ot MD176
Applicant
Medical Wire & Equipment Co.
Fairview Park, OH, US
Received
June 9, 1987
Decision date
June 23, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JSM – Culture Media, Non-Propagating Transport
Device class
Class I (low risk)
Regulation
21 CFR 866.2390
Specialty
Microbiology

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Questions and answers

When was Transtube MW176 Ot MD176 cleared by the FDA?

Transtube MW176 Ot MD176 (K872213) received a 510(k) decision of Substantially Equivalent on June 23, 1987, 14 days after the submission was received.

What is the product code of K872213?

The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.