Ana-Disc System
FDA 510(k) K820308 · Flow Laboratories, Inc.
510(k) numberK820308
Submission
- Device name
- Ana-Disc System
- Applicant
- Flow Laboratories, Inc.
Mchenry, IL, US - Received
- February 4, 1982
- Decision date
- March 4, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZJ – Device, Gas Generating
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2580
- Specialty
- Microbiology
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Questions and answers
When was Ana-Disc System cleared by the FDA?
Ana-Disc System (K820308) received a 510(k) decision of Substantially Equivalent on March 4, 1982, 28 days after the submission was received.
What is the product code of K820308?
The FDA product code is KZJ – Device, Gas Generating, a Class I (low risk) device regulated under 21 CFR 866.2580.