Accuprobe Streptococcus Pneumoniae Culture Confir.
FDA 510(k) K902908 · Gen-Probe, Inc.
510(k) numberK902908
Submission
- Device name
- Accuprobe Streptococcus Pneumoniae Culture Confir.
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- July 2, 1990
- Decision date
- August 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MCT – Dna-Probe, Strep Pneumoniae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
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Questions and answers
When was Accuprobe Streptococcus Pneumoniae Culture Confir. cleared by the FDA?
Accuprobe Streptococcus Pneumoniae Culture Confir. (K902908) received a 510(k) decision of Substantially Equivalent on August 6, 1990, 35 days after the submission was received.
What is the product code of K902908?
The FDA product code is MCT – Dna-Probe, Strep Pneumoniae, a Class I (low risk) device regulated under 21 CFR 866.3740.