DRX NTX or, Osteomark NTX Direct Response
FDA 510(k) K984530 · Metrika, Inc.
510(k) numberK984530
Submission
- Device name
- DRX NTX or, Osteomark NTX Direct Response
- Applicant
- Metrika, Inc.
Los Angeles, CA, US - Received
- December 21, 1998
- Decision date
- August 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFY – Enzymatic Method, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252619 | Qscheck UisacrJFY · Traditional | Qstag, Inc. | 02/20/2026SE |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3)JFY · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/24/2021SE |
| K193649 | Yumizen C1200 Creatinine PAPJFY · Traditional | Horiba Abx SAS | 05/10/2021SE |
| K182384 | ACR LAB Urine Analysis Test SystemJFY · Traditional | Healthy.Io, Ltd. | 07/26/2019SE |
| K183555 | GEM Premier ChemSTATJFY · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerJFY · Traditional | Yd Diagnostics Corporation | 12/10/2018SE |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…JFY · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/30/2018SE |
| K161527 | Teco Creatinine Enzymatic Reagent KitJFY · Traditional | Teco Diagnostics, Inc. | 07/21/2017SE |
| K152835 | Uritek TC-201 Urine Chemistry Test SystemJFY · Traditional | Teco Diagnostics, Inc. | 03/07/2016SE |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…JFY · Traditional | ACON Laboratories, Inc. | 12/22/2014SE |
More from ACON Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051321 | InviewLCP · Special | 06/13/2005SE |
| K033847 | A1CNOW for Home and Professional UseLCP · Special | 12/23/2003SE |
| K022661 | A1CNOW for Home UseLCP · Traditional | 12/13/2002SE |
| K020235 | A1CNOW for Professional UseLCP · Special | 02/15/2002SE |
| K020234 | A1CNOW for RX Home UseLCP · Special | 02/15/2002SE |
| K000885 | DRX HBA1C - for Prescription Home UseLCP · Traditional | 09/26/2000SE |
| K000887 | DRX HBA1CLCP · Traditional | 07/26/2000SE |
| K992997 | Osteomark NTX PocJMM · Traditional | 11/09/1999SE |
| K991532 | DRX Qt. HCGDHA · Traditional | 09/17/1999SE |
| K991917 | Osteomark NTX Point of Care (Poc) Control SetJJW · Traditional | 07/12/1999SE |
Questions and answers
When was DRX NTX or, Osteomark NTX Direct Response cleared by the FDA?
DRX NTX or, Osteomark NTX Direct Response (K984530) received a 510(k) decision of Substantially Equivalent on August 10, 1999, 232 days after the submission was received.
What is the product code of K984530?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.