Osteomark NTX Point of Care (Poc) Control Set
FDA 510(k) K991917 · Metrika, Inc.
510(k) numberK991917
Submission
- Device name
- Osteomark NTX Point of Care (Poc) Control Set
- Applicant
- Metrika, Inc.
Sunnyvale, CA, US - Received
- June 7, 1999
- Decision date
- July 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJW – Urinalysis Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170091 | UA-Cellular CompleteJJW · Traditional | Streck | 02/09/2017SE |
| K142262 | Aution Check PlusJJW · Traditional | Quantimetrix Corp. | 04/10/2015SE |
| K131444 | Ua-Cellular CompleteJJW · Traditional | Streck | 01/29/2014SE |
| K110846 | Randox Urinalysis Controls, Levels 1 and 2JJW · Traditional | Randox Laboratories Limited | 09/30/2011SE |
| K103387 | Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip…JJW · Traditional | ACON Laboratories, Inc. | 02/02/2011SE |
| K081908 | Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2JJW · Traditional | Cliniqa Corporation | 01/16/2009SE |
| K072640 | Irispec,Ca/Cb/CcJJW · Abbreviated | Iris Diagnostics | 12/21/2007SE |
| K070848 | Liquichek Urinalysis Control (Bi-Level), Control LEVEL1, Level 2,MINIPAK, 435,436,437,435XJJW · Traditional | Bio-Rad, Diagnostics Grp. | 04/25/2007SE |
| K052242 | Advia Chemistry Microalbumin ControlsJJW · Abbreviated | Bayer Healthcare, LLC | 10/03/2005SE |
| K043266 | Randox Urine ControlsJJW · Traditional | Randox Laboratories, Ltd. | 02/15/2005SE |
More from Randox Laboratories, Ltd.
| 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 |
| K984530 | DRX NTX or, Osteomark NTX Direct ResponseJFY · Traditional | 08/10/1999SE |
Questions and answers
When was Osteomark NTX Point of Care (Poc) Control Set cleared by the FDA?
Osteomark NTX Point of Care (Poc) Control Set (K991917) received a 510(k) decision of Substantially Equivalent on July 12, 1999, 35 days after the submission was received.
What is the product code of K991917?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.