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 |