Beckman Synchron Lactate Reagent
FDA 510(k) K934271 · Beckman-Diagnostic Systems Group
510(k) numberK934271
Submission
- Device name
- Beckman Synchron Lactate Reagent
- Applicant
- Beckman-Diagnostic Systems Group
Brea, CA, US - Received
- August 31, 1993
- Decision date
- November 9, 1993
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K945522 | I.D.-Zone Immunofixation Electrophoresis ControlsDFT · Traditional | 12/12/1994SE |
| K944605 | CX Phencyclidine Reagent for Synschron CX SystemLCM · Traditional | 12/07/1994SE |
| K944604 | CX Amphetamines Reagent for Synchron CX SystemsDKZ · Traditional | 12/07/1994SE |
| K944606 | CX Opiate Reagent for Synchron CX SystemsDJG · Traditional | 11/30/1994SE |
| K942676 | Synchron CX3 DeltaJJF · Traditional | 11/02/1994SE |
| K934293 | Beckman Pancreatic Amylase (Pamy) ReagentJFJ · Traditional | 07/06/1994SE |
| K934068 | Beckman Direct Bilirubin ReagentCIG · Traditional | 04/26/1994SE |
| K936184 | Vigil PRX Chemistry ControlJJY · Traditional | 04/15/1994SE |
| K934046 | Beckman Cholesterol ReagentCHH · Traditional | 10/28/1993SE |
| K934467 | Beckman CX Ammonia/Alcohol ControlDKC · Traditional | 10/27/1993SE |
Questions and answers
When was Beckman Synchron Lactate Reagent cleared by the FDA?
Beckman Synchron Lactate Reagent (K934271) received a 510(k) decision of Substantially Equivalent on November 9, 1993, 70 days after the submission was received.
What is the product code of K934271?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.