Hemoglobin Control
FDA 510(k) K802568 · Marilyn L. Amick
510(k) numberK802568
Submission
- Device name
- Hemoglobin Control
- Applicant
- Marilyn L. Amick
Mchenry, IL, US - Received
- October 17, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K973649 | Hemosite Test SystemKHG · Traditional | Gds Technology, LLC | 08/31/1998SE |
| 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 |
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Questions and answers
When was Hemoglobin Control cleared by the FDA?
Hemoglobin Control (K802568) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 26 days after the submission was received.
What is the product code of K802568?
The FDA product code is KHG – Whole Blood Hemoglobin Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7500.