Oximeter, Co-, Il Model 282
FDA 510(k) K760208 · Instrumentation Laboratory CO
510(k) numberK760208
Submission
- Device name
- Oximeter, Co-, Il Model 282
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- July 9, 1976
- Decision date
- July 26, 1976
- 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
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|---|---|---|---|
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| 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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| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
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Questions and answers
When was Oximeter, Co-, Il Model 282 cleared by the FDA?
Oximeter, Co-, Il Model 282 (K760208) received a 510(k) decision of Substantially Equivalent on July 26, 1976, 17 days after the submission was received.
What is the product code of K760208?
The FDA product code is KHG – Whole Blood Hemoglobin Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7500.