Roche Lactate Analyzer 640
FDA 510(k) K790421 · Roche Medical Electronics, Inc.
510(k) numberK790421
Submission
- Device name
- Roche Lactate Analyzer 640
- Applicant
- Roche Medical Electronics, Inc.
Mchenry, IL, US - Received
- February 28, 1979
- Decision date
- May 15, 1979
- Decision
- Substantially Equivalent (SESE)
- 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
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 |
More from I-Stat Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K791559 | Roche Sensor AdaptorKLK · Traditional | 11/21/1979SE |
| K791039 | Fetasonde Fetal Heart Rate VariabilityHGM · Traditional | 09/04/1979SE |
| K791038 | Fetasonde Uterine Activity MonitorHGM · Traditional | 09/04/1979SE |
| K791037 | Fetasonde Labor Status DisplayHGM · Traditional | 09/04/1979SE |
| K791036 | Fetasonde Uterine Work MonitorHGM · Traditional | 09/04/1979SE |
| K791035 | Fetasonde Fetal Activity MonitorHGM · Traditional | 09/04/1979SE |
| K790761 | Fetasonde Model 2108HGM · Traditional | 06/01/1979SE |
| K782089 | Monitor, Heart Rate Model 103DRT · Traditional | 01/04/1979SE |
| K782088 | Monitor, Heart Rate Model 105DRT · Traditional | 01/04/1979SE |
| K781271 | Monitor, PO2, IntravascularCCE · Traditional | 10/12/1978SE |
Questions and answers
When was Roche Lactate Analyzer 640 cleared by the FDA?
Roche Lactate Analyzer 640 (K790421) received a 510(k) decision of Substantially Equivalent on May 15, 1979, 76 days after the submission was received.
What is the product code of K790421?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.