Bun Reagnet Set
FDA 510(k) K780069 · Medical Analysis Systems, Inc.
510(k) numberK780069
Submission
- Device name
- Bun Reagnet Set
- Applicant
- Medical Analysis Systems, Inc.
Mchenry, IL, US - Received
- January 16, 1978
- Decision date
- February 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
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| K021385 | Atac Pak Bun ReagentCDQ · Traditional | Elan Diagnostics | 07/12/2002SE |
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Questions and answers
When was Bun Reagnet Set cleared by the FDA?
Bun Reagnet Set (K780069) received a 510(k) decision of Substantially Equivalent on February 14, 1978, 29 days after the submission was received.
What is the product code of K780069?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.