Easy-Test Lactic Acid (la)
FDA 510(k) K880787 · Diagnostic Systems
510(k) numberK880787
Submission
- Device name
- Easy-Test Lactic Acid (la)
- Applicant
- Diagnostic Systems
Gibbstown, NJ, US - Received
- February 26, 1988
- Decision date
- March 15, 1988
- 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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| K905146 | Olympus Urine PHJQY · Traditional | 02/04/1991SE |
| K893691 | Emds Creatine Kinase Item Nimber 65411CGS · Traditional | 08/31/1989SE |
| K893692 | Emds Aspartate Aminotransferase Item Number 65405CIT · Traditional | 08/21/1989SE |
| K893966 | HDL Precipitating ReagentLBR · Traditional | 07/25/1989SE |
| K884993 | Visual Blood Glucose Test SystemCGA · Traditional | 12/29/1988SE |
| K881116 | Easy-Test Emit(R) Lidocaine Lido Item No. 16641KLR · Traditional | 06/20/1988SE |
| K862403 | Emds Antiepileptic Drug Calibrators Item #67630/95DKB · Traditional | 07/11/1986SE |
| K854784 | Absorbance (Abs) Test PakJIT · Traditional | 12/19/1985SE |
| K853699 | Easy Analyzer & Easy-Test ReagentJJE · Traditional | 09/25/1985SE |
| K853533 | Absorbance Test SolutionJIT · Traditional | 09/16/1985SE |
Questions and answers
When was Easy-Test Lactic Acid (la) cleared by the FDA?
Easy-Test Lactic Acid (la) (K880787) received a 510(k) decision of Substantially Equivalent on March 15, 1988, 18 days after the submission was received.
What is the product code of K880787?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.