Urine Monovette Boric Acid
FDA 510(k) K024237 · Sarstedt, Inc.
510(k) numberK024237
Submission
- Device name
- Urine Monovette Boric Acid
- Applicant
- Sarstedt, Inc.
Newton, NC, US - Received
- December 23, 2002
- Decision date
- April 14, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Urine Monovette Boric Acid cleared by the FDA?
Urine Monovette Boric Acid (K024237) received a 510(k) decision of Substantially Equivalent on April 14, 2003, 112 days after the submission was received.
What is the product code of K024237?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.