Anemiapro Self-Screener
FDA 510(k) K042379 · Biosafe Laboratories, Inc.
510(k) numberK042379
Submission
- Device name
- Anemiapro Self-Screener
- Applicant
- Biosafe Laboratories, Inc.
Lake Forest, IL, US - Received
- September 1, 2004
- Decision date
- December 15, 2004
- 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 |
| 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 |
| K885227 | Clinistat Hemoglobin Reagent TestKHG · Traditional | Heraeus Kulzer, Inc. | 02/24/1989SE |
More from Heraeus Kulzer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012221 | Safe at Home Cholesterol Profile Blood Collection and Transport SystemJKA · Traditional | 04/03/2002SE |
| K011970 | Biosafe Cholesterol Profile Blood Collection and Transport SystemCHH · Traditional | 09/26/2001SE |
| K011525 | Safe at Home TSH (Thyroid Stimulating Hormone Blood Collection and Transport System)JLW · Traditional | 07/16/2001SE |
| K003752 | Biosafe Capillary Blood Transport System for Testing Thyroid Stimulating Hormone (TSH)JLW · Traditional | 03/23/2001SE |
| K991850 | Safe At-Home Test Kit for Monitoring Hemoglobin AlcLCP · Traditional | 11/26/1999SE |
Questions and answers
When was Anemiapro Self-Screener cleared by the FDA?
Anemiapro Self-Screener (K042379) received a 510(k) decision of Substantially Equivalent on December 15, 2004, 105 days after the submission was received.
What is the product code of K042379?
The FDA product code is KHG – Whole Blood Hemoglobin Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7500.