The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra 400 Clinical Chemistry Analyzer (option: I.s.e. Module).
Device ID | K052007 |
510k Number | K052007 |
Device Name: | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) |
Classification | Hexokinase, Glucose |
Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
Contact | Tim Lawton |
Correspondent | Tim Lawton HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
Product Code | CFR |
Subsequent Product Code | CEM |
Subsequent Product Code | CGZ |
Subsequent Product Code | JGS |
Subsequent Product Code | JIX |
Subsequent Product Code | JJE |
Subsequent Product Code | JJY |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-25 |
Decision Date | 2005-12-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03610230006757 | K052007 | 000 |
03610230005217 | K052007 | 000 |
03610230005880 | K052007 | 000 |
03610230005897 | K052007 | 000 |
03610230005903 | K052007 | 000 |
03610230006528 | K052007 | 000 |
03610230006535 | K052007 | 000 |
03610230006542 | K052007 | 000 |
03610230006559 | K052007 | 000 |
03610230006740 | K052007 | 000 |
03610230005200 | K052007 | 000 |