Abbott Vision Hemoglobin (Modification)
FDA 510(k) K953221 · Abbott Laboratories
510(k) numberK953221
Submission
- Device name
- Abbott Vision Hemoglobin (Modification)
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- June 19, 1995
- Decision date
- September 29, 1995
- 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
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| 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 |
| 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 |
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Questions and answers
When was Abbott Vision Hemoglobin (Modification) cleared by the FDA?
Abbott Vision Hemoglobin (Modification) (K953221) received a 510(k) decision of Substantially Equivalent on September 29, 1995, 102 days after the submission was received.
What is the product code of K953221?
The FDA product code is KHG – Whole Blood Hemoglobin Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7500.