Ysi Model 1500 Sport L-Lactate Analyzer
FDA 510(k) K901131 · Yellow Springs Instrument Co., Inc.
510(k) numberK901131
Submission
- Device name
- Ysi Model 1500 Sport L-Lactate Analyzer
- Applicant
- Yellow Springs Instrument Co., Inc.
Yellow Springs, OH, US - Received
- March 12, 1990
- Decision date
- August 27, 1990
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHP – Acid, Lactic, Enzymatic Method
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1450
- Specialty
- Clinical Chemistry
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| K113216 | Rapidpoint 500 Blood Gas AnalyerKHP · Traditional | Siemens Healthcare Diagnostics | 05/03/2012SE |
| K112955 | Nova Statstrip Lactate Hospital Meter SystemKHP · Traditional | Nova Biomedical Corporation | 01/05/2012SE |
| K112430 | I-Stat Lactate Test/I-Sat CG4+CARTRIDGEKHP · Traditional | Abbott Pont of Care, Inc. | 12/20/2011SE |
| K100602 | Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsKHP · Traditional | Nova Biomedical Corp. | 08/17/2011SE |
| K093297 | Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeKHP · Traditional | Epocal, Inc. | 06/09/2010SE |
| K013938 | Irma SL Blood Analysis System Lactate CartridgeKHP · Traditional | Diametrics Medical, Inc. | 01/28/2002SE |
| K011478 | I-Stat SystemKHP · Traditional | I-Stat Corp. | 07/02/2001SE |
| K980908 | Lactate Pro SystemKHP · Traditional | Kdk Corp. | 09/11/1998SE |
| K982071 | I-Stat Lactate TestKHP · Traditional | I-Stat Corp. | 06/29/1998SE |
More from I-Stat Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K962070 | Ysi 400 Series Atuoclavable Reusable Temperature ProbeFLL · Traditional | 07/19/1996SE |
| K922821 | Ysi Models 4700 Foley Catheter Temperature ProbesEZL · Traditional | 11/23/1992SE |
| K922007 | Ysi Model 441A Airway Temperature ProbeBZT · Traditional | 11/04/1992SE |
| K910633 | Ysi Model 1500 Blood Glucose AnalyzerCGA · Traditional | 04/12/1991SE |
| K910718 | Ysi Precision 4000 ThermometerFLL · Traditional | 04/09/1991SE |
| K893409 | Ysi Models 4400 & 4700 Esophageal Stethoscope TempBZT · Traditional | 07/20/1989SE |
| K891480 | Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerCGA · Traditional | 05/22/1989SE |
| K883793 | Disposable Temperature Probes (Several Models)FLL · Traditional | 11/21/1988SE |
| K865012 | Ysi Model 801FMT · Traditional | 03/04/1987SE |
| K853551 | Ysi Model 790 Tele-ThermometerFLL · Traditional | 09/19/1985SE |
Questions and answers
When was Ysi Model 1500 Sport L-Lactate Analyzer cleared by the FDA?
Ysi Model 1500 Sport L-Lactate Analyzer (K901131) received a 510(k) decision of Substantially Equivalent for Some Indications on August 27, 1990, 168 days after the submission was received.
What is the product code of K901131?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.