The following data is part of a premarket notification filed by Gds Technology with the FDA for Stat-site Mhgb Meter, Stat-site Mhgb Meter Card Holder, Stat-site Mhgb Test Cards, Stat-site Mhgb Code Way, Models 90090.
| Device ID | K020138 |
| 510k Number | K020138 |
| Device Name: | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | GDS TECHNOLOGY 25235 LEER DR. Elkhart, IN 46514 |
| Contact | Richard Tyhach |
| Correspondent | Richard Tyhach GDS TECHNOLOGY 25235 LEER DR. Elkhart, IN 46514 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-16 |
| Decision Date | 2002-02-11 |