System 6300 Series High Performance Amino Acid Ana
FDA 510(k) K925093 · Beckman Instruments, Inc.
510(k) numberK925093
Submission
- Device name
- System 6300 Series High Performance Amino Acid Ana
- Applicant
- Beckman Instruments, Inc.
Palo Alto, CA, US - Received
- October 7, 1992
- Decision date
- November 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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Questions and answers
When was System 6300 Series High Performance Amino Acid Ana cleared by the FDA?
System 6300 Series High Performance Amino Acid Ana (K925093) received a 510(k) decision of Substantially Equivalent on November 16, 1993, 405 days after the submission was received.
What is the product code of K925093?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.