Quadra Titer Micro Plates
FDA 510(k) K850725 · Microtech Medical Systems, Inc.
510(k) numberK850725
Submission
- Device name
- Quadra Titer Micro Plates
- Applicant
- Microtech Medical Systems, Inc.
Aurora, CO, US - Received
- February 22, 1985
- Decision date
- April 30, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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| K852613 | Mic-Concept SystemLTW · Traditional | 09/20/1985SE |
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Questions and answers
When was Quadra Titer Micro Plates cleared by the FDA?
Quadra Titer Micro Plates (K850725) received a 510(k) decision of Substantially Equivalent on April 30, 1985, 67 days after the submission was received.
What is the product code of K850725?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.