Mas Liquid Urinalysis Control Level 1, Level 2 and Level 3
FDA 510(k) K973451 · Medical Analysis Systems, Inc.
510(k) numberK973451
Submission
- Device name
- Mas Liquid Urinalysis Control Level 1, Level 2 and Level 3
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- September 11, 1997
- Decision date
- September 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K042717 | Mas, Dade and Liquid Assayed Diabetes ControlJJX · Traditional | 11/05/2004SE |
| K041194 | Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and HJJX · Traditional | 08/16/2004SE |
| K040880 | Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3JJY · Traditional | 04/28/2004SE |
| K032826 | Mas Par TDMDIF · Traditional | 10/09/2003SE |
| K032335 | Mas Cardioimmune Probnp, Mas Cardioimmune TLJJY · Traditional | 08/19/2003SE |
| K031890 | Mas Bilirubin Liquid Assayed Bilirubin ControlJJX · Traditional | 07/16/2003SE |
| K031441 | Urichemtrak Liquid Assayed Urine ControlJJW · Traditional | 07/01/2003SE |
| K031392 | Mas Tox Ammonia Controlliquid Assayed Tox Ammonia ControlDKC · Traditional | 07/01/2003SE |
| K031364 | Mas Cardiolmmune Probnp Liquid Assayed Cardiac Marker Control Level 1, 2 and 3JJY · Traditional | 05/30/2003SE |
| K030942 | Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry ControlJJY · Traditional | 04/28/2003SE |
Questions and answers
When was Mas Liquid Urinalysis Control Level 1, Level 2 and Level 3 cleared by the FDA?
Mas Liquid Urinalysis Control Level 1, Level 2 and Level 3 (K973451) received a 510(k) decision of Substantially Equivalent on September 29, 1997, 18 days after the submission was received.
What is the product code of K973451?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.