Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips
FDA 510(k) K100602 · Nova Biomedical Corp.
510(k) numberK100602
Submission
- Device name
- Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips
- Applicant
- Nova Biomedical Corp.
Walham, MA, US - Received
- March 3, 2010
- Decision date
- August 17, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHP – Acid, Lactic, Enzymatic Method
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1450
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KHP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130113 | Piccolo Lactate Test SystemKHP · Traditional | Abaxis, Inc. | 03/11/2013SE |
| 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 |
| 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 |
| K971944 | Lactest IKHP · Traditional | Jwt, Inc. | 12/17/1997SE |
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| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | 09/29/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | 10/18/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | 04/14/2020SE |
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Questions and answers
When was Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips cleared by the FDA?
Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips (K100602) received a 510(k) decision of Substantially Equivalent on August 17, 2011, 532 days after the submission was received.
What is the product code of K100602?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.