CX Alanine, CX Aspartate AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX Creatine Phosphokinase-N-Acetyl-L-Cysteine
FDA 510(k) K952427 · Beckman Instruments, Inc.
510(k) numberK952427
Submission
- Device name
- CX Alanine, CX Aspartate AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX Creatine Phosphokinase-N-Acetyl-L-Cysteine
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- May 24, 1995
- Decision date
- September 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
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Questions and answers
When was CX Alanine, CX Aspartate AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX Creatine Phosphokinase-N-Acetyl-L-Cysteine cleared by the FDA?
CX Alanine, CX Aspartate AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX Creatine Phosphokinase-N-Acetyl-L-Cysteine (K952427) received a 510(k) decision of Substantially Equivalent on September 21, 1995, 120 days after the submission was received.
What is the product code of K952427?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.