10B Arginine Broth
FDA 510(k) K961046 · Remel, L.P.
510(k) numberK961046
Submission
- Device name
- 10B Arginine Broth
- Applicant
- Remel, L.P.
Lenexa, KS, US - Received
- March 15, 1996
- Decision date
- September 18, 1996
- 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 10B Arginine Broth cleared by the FDA?
10B Arginine Broth (K961046) received a 510(k) decision of Substantially Equivalent on September 18, 1996, 187 days after the submission was received.
What is the product code of K961046?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.