Lactest I
FDA 510(k) K971944 · Jwt, Inc.
510(k) numberK971944
Submission
- Device name
- Lactest I
- Applicant
- Jwt, Inc.
Bethlehem, PA, US - Received
- May 27, 1997
- Decision date
- December 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
Questions and answers
When was Lactest I cleared by the FDA?
Lactest I (K971944) received a 510(k) decision of Substantially Equivalent on December 17, 1997, 204 days after the submission was received.
What is the product code of K971944?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.