Hemosite Test System
FDA 510(k) K973649 · Gds Technology, LLC
510(k) numberK973649
Submission
- Device name
- Hemosite Test System
- Applicant
- Gds Technology, LLC
Elkhart, IN, US - Received
- September 25, 1997
- Decision date
- August 31, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHG – Whole Blood Hemoglobin Determination
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Specialty
- Hematology
Other 510(k)s with product code KHG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221508 | AnemoCheck HomeKHG · Traditional | Sanguina, Inc. | 09/29/2023SE |
| K163215 | AnemoCheckKHG · Traditional | Sanguina, LLC | 09/13/2017SE |
| K042379 | Anemiapro Self-ScreenerKHG · Traditional | Biosafe Laboratories, Inc. | 12/15/2004SE |
| K020138 | Stat-Site MHGB Meter, Stat-Site MHGB Meter Card Holder, Stat-Site MHGB Test Cards…KHG · Special | Gds Technology | 02/11/2002SE |
| K001462 | Careside HemoglobinKHG · Traditional | Careside, Inc. | 08/21/2000SE |
| K994073 | Hemosite Test SystemKHG · Traditional | Gds Technology, LLC | 01/14/2000SE |
| K953221 | Abbott Vision Hemoglobin (Modification)KHG · Traditional | Abbott Laboratories | 09/29/1995SE |
| K934064 | Reflotron Hemoglobin Test TabsKHG · Traditional | Boehringer Mannheim Corp. | 12/06/1993SE |
| K895101 | Biotrack Hemoglobin Test CartridgeKHG · Traditional | Biotrack, Inc. | 10/10/1989SE |
| K885227 | Clinistat Hemoglobin Reagent TestKHG · Traditional | Heraeus Kulzer, Inc. | 02/24/1989SE |
More from Heraeus Kulzer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K020138 | Stat-Site MHGB Meter, Stat-Site MHGB Meter Card Holder, Stat-Site MHGB Test Cards…KHG · Special | 02/11/2002SE |
| K994073 | Hemosite Test SystemKHG · Traditional | 01/14/2000SE |
| K992132 | Cholesite Test SystemCHH · Traditional | 08/20/1999SE |
| K971145 | Glucosite Test SystemCGA · Traditional | 09/17/1997SE |
| K911801 | Ketosite(Tm)/Stat-Site(Tm)/Ketosite(Tm) Low-Hi ConJIN · Traditional | 07/01/1991SE |
| K882038 | GDS Enzymatic Salicylate ReagentDKJ · Traditional | 06/24/1988SE |
| K880829 | GDS Enzymatic Acetaminophen ReagentLDP · Traditional | 05/27/1988SE |
Questions and answers
When was Hemosite Test System cleared by the FDA?
Hemosite Test System (K973649) received a 510(k) decision of Substantially Equivalent on August 31, 1998, 340 days after the submission was received.
What is the product code of K973649?
The FDA product code is KHG – Whole Blood Hemoglobin Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7500.