Septi-Chek Schaedler Med. Blood Culture Bottle-Roc
FDA 510(k) K851249 · Roche Diagnostic Systems, Inc.
510(k) numberK851249
Submission
- Device name
- Septi-Chek Schaedler Med. Blood Culture Bottle-Roc
- Applicant
- Roche Diagnostic Systems, Inc.
Nutley, NJ, US - Received
- March 27, 1985
- Decision date
- April 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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Questions and answers
When was Septi-Chek Schaedler Med. Blood Culture Bottle-Roc cleared by the FDA?
Septi-Chek Schaedler Med. Blood Culture Bottle-Roc (K851249) received a 510(k) decision of Substantially Equivalent on April 22, 1985, 26 days after the submission was received.
What is the product code of K851249?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.