Gen-Probe Mycoplasma Pneumonia Rapid Detect System
FDA 510(k) K860574 · Gen-Probe, Inc.
510(k) numberK860574
Submission
- Device name
- Gen-Probe Mycoplasma Pneumonia Rapid Detect System
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- February 14, 1986
- Decision date
- July 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQG – Dna-Reagents, Mycoplasma Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3375
- Specialty
- Microbiology
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Questions and answers
When was Gen-Probe Mycoplasma Pneumonia Rapid Detect System cleared by the FDA?
Gen-Probe Mycoplasma Pneumonia Rapid Detect System (K860574) received a 510(k) decision of Substantially Equivalent on July 3, 1986, 139 days after the submission was received.
What is the product code of K860574?
The FDA product code is LQG – Dna-Reagents, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.