Supplementary Reagents for Enzygnost/Tmb
FDA 510(k) K920416 · Behring Diagnostics, Inc.
510(k) numberK920416
Submission
- Device name
- Supplementary Reagents for Enzygnost/Tmb
- Applicant
- Behring Diagnostics, Inc.
Somerville, NJ, US - Received
- January 31, 1992
- Decision date
- April 8, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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Questions and answers
When was Supplementary Reagents for Enzygnost/Tmb cleared by the FDA?
Supplementary Reagents for Enzygnost/Tmb (K920416) received a 510(k) decision of Substantially Equivalent on April 8, 1992, 68 days after the submission was received.
What is the product code of K920416?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.