Septi-Check Blood Culture Slide
FDA 510(k) K812731 · Hoffmann-La Roche, Inc.
510(k) numberK812731
Submission
- Device name
- Septi-Check Blood Culture Slide
- Applicant
- Hoffmann-La Roche, Inc.
Mchenry, IL, US - Received
- September 28, 1981
- Decision date
- October 19, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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Questions and answers
When was Septi-Check Blood Culture Slide cleared by the FDA?
Septi-Check Blood Culture Slide (K812731) received a 510(k) decision of Substantially Equivalent on October 19, 1981, 21 days after the submission was received.
What is the product code of K812731?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.