The following data is part of a premarket notification filed by Abx, Inc. with the FDA for Vega Hematology Analyzer.
Device ID | K962633 |
510k Number | K962633 |
Device Name: | VEGA HEMATOLOGY ANALYZER |
Classification | Counter, Differential Cell |
Applicant | ABX, INC. RUE DU CADUCEE-BP7290 Montpellier Cedex 4, FR 34184 |
Contact | Brice Prouve |
Correspondent | Brice Prouve ABX, INC. RUE DU CADUCEE-BP7290 Montpellier Cedex 4, FR 34184 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-05 |
Decision Date | 1996-11-04 |
Summary: | summary |