Imipenem Antimicrobial Susceptibility Test Disc
FDA 510(k) K964487 · Unipath , Ltd.
510(k) numberK964487
Submission
- Device name
- Imipenem Antimicrobial Susceptibility Test Disc
- Applicant
- Unipath , Ltd.
Beverly, MA, US - Received
- November 7, 1996
- Decision date
- February 7, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JTN – Susceptibility Test Discs, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1620
- Specialty
- Microbiology
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Questions and answers
When was Imipenem Antimicrobial Susceptibility Test Disc cleared by the FDA?
Imipenem Antimicrobial Susceptibility Test Disc (K964487) received a 510(k) decision of Substantially Equivalent on February 7, 1997, 92 days after the submission was received.
What is the product code of K964487?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.