Quantimetrix Total Creatine Kinase Control
FDA 510(k) K874302 · Quantimetrix Medical Industries
510(k) numberK874302
Submission
- Device name
- Quantimetrix Total Creatine Kinase Control
- Applicant
- Quantimetrix Medical Industries
Hawthorne, CA, US - Received
- October 20, 1987
- Decision date
- February 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJT – Enzyme Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K993723 | Cardiasure Cardiac Markers ControlJJT · Traditional | Quantimetrix Corp. | 11/23/1999SE |
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| K992430 | Cardioimmune Cardiac Marker Control Levels 1,2, and 3JJT · Traditional | Medical Analysis Systems, Inc. | 08/30/1999SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K895778 | Quantimetrix Bilirubin CalibratorsJIS · Traditional | 11/14/1989SE |
| K883395 | Alkphor(Tm) System, Human Serum Alka Phos IsoenzyJJT · Traditional | 09/19/1988SE |
| K883247 | Lipophor(Tm) Syst, Human Serum Lipoprotein ControlJJY · Traditional | 09/13/1988SE |
| K874890 | Quantimetrix Urine Dipstick ControlJJW · Traditional | 01/21/1988SE |
| K873011 | Quantimetrix Serum Alcohol Control Level 1 and 2LAS · Traditional | 10/29/1987SE |
| K873467 | Quantimetrix Urine Drugs of Abuse ControlDIF · Traditional | 09/29/1987SE |
| K861448 | Quantimetrix Serum Lipid Control I & II LiquidJJY · Traditional | 04/28/1986SE |
Questions and answers
When was Quantimetrix Total Creatine Kinase Control cleared by the FDA?
Quantimetrix Total Creatine Kinase Control (K874302) received a 510(k) decision of Substantially Equivalent on February 2, 1988, 105 days after the submission was received.
What is the product code of K874302?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.