Hemoglobin Reagent
FDA 510(k) K823060 · Biorent Diagnostic, Inc.
510(k) numberK823060
Submission
- Device name
- Hemoglobin Reagent
- Applicant
- Biorent Diagnostic, Inc.
Mchenry, IL, US - Received
- October 18, 1982
- Decision date
- November 22, 1982
- 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
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|---|---|---|---|
| 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 |
More from Biotrack, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K832747 | Albumin Reagent SetCIX · Traditional | 10/14/1983SE |
| K823211 | Ck-Uv ReagentJHS · Traditional | 11/22/1982SE |
| K822494 | Optimized Uv-Gpt Reagent SetCKA · Traditional | 09/21/1982SE |
| K822493 | Optimized Uv-Got Reagent SetCIT · Traditional | 09/21/1982SE |
| K822492 | Optimized Uv-Ldh Reagent SetCFJ · Traditional | 09/17/1982SE |
| K820768 | Colorimetric LDH Reagent SetCFH · Traditional | 04/14/1982SE |
| K820632 | Colorimetric Uric Acid Reagent SetKNK · Traditional | 03/25/1982SE |
| K813555 | Glucose Enzyme-Color Reagent SetCGA · Traditional | 01/18/1982SE |
| K813244 | UV Uric Acid DeterminationCDO · Traditional | 12/08/1981SE |
| K811760 | Cholesterol DeterminationCHH · Traditional | 07/10/1981SE |
Questions and answers
When was Hemoglobin Reagent cleared by the FDA?
Hemoglobin Reagent (K823060) received a 510(k) decision of Substantially Equivalent on November 22, 1982, 35 days after the submission was received.
What is the product code of K823060?
The FDA product code is KHG – Whole Blood Hemoglobin Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7500.