Synchron Lactate Reagent
FDA 510(k) K910534 · Beckman Instruments, Inc.
510(k) numberK910534
Submission
- Device name
- Synchron Lactate Reagent
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- February 8, 1991
- Decision date
- April 8, 1991
- 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
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| 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 |
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Questions and answers
When was Synchron Lactate Reagent cleared by the FDA?
Synchron Lactate Reagent (K910534) received a 510(k) decision of Substantially Equivalent on April 8, 1991, 59 days after the submission was received.
What is the product code of K910534?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.