The following data is part of a premarket notification filed by Wako Chemicals Usa, Inc. with the FDA for Apolowako Hba1c, Glucose And Analyzer, Models 993-24601, 991-24401 And 993-25201.
| Device ID | K080123 |
| 510k Number | K080123 |
| Device Name: | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 |
| Classification | Hexokinase, Glucose |
| Applicant | WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Peter Panfili |
| Correspondent | Peter Panfili WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-17 |
| Decision Date | 2008-07-17 |
| Summary: | summary |