FDA 510(k)

CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE

K-Number: K952427 · 1995-09-21

Decision Date1995-09-21

Product CodeCKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1995-09-21 under 510(k) number K952427. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE?

CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE is a medical device that received FDA 510(k) clearance on 1995-09-21. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K952427.

When did CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE receive FDA 510(k) clearance?

CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE received FDA 510(k) clearance on 1995-09-21, under 510(k) number K952427.

Who is the listed applicant for CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE?

The FDA 510(k) record lists Beckman Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE?

The FDA product code for CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE is CKA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.