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

Nadh Oxidation/nad Reduction, Alt/sgpt

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Cx Alanine, Cx Aspartate Aminotransferase-pyridoxal-5-phosphate, Cx Creatine Phosphokinase-n-acetyl-l-cysteine.

Pre-market Notification Details

• Device ID: K952427
• 510k Number: K952427
• Device Name: CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE
• Classification: Nadh Oxidation/nad Reduction, Alt/sgpt
• Applicant: BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea, CA 92821 -6208
• Contact: Don W Hart
• Correspondent: Don W Hart; BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea, CA 92821 -6208
• Product Code: CKA
• Subsequent Product Code: CGS
• Subsequent Product Code: CIT
• CFR Regulation Number: 862.1030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-05-24
• Decision Date: 1995-09-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590575106	K952427	000
15099590575076	K952427	000
15099590222666	K952427	000