Quantimetrix Serum Alcohol Control Level 1 and 2
FDA 510(k) K873011 · Quantimetrix Medical Industries
510(k) numberK873011
Submission
- Device name
- Quantimetrix Serum Alcohol Control Level 1 and 2
- Applicant
- Quantimetrix Medical Industries
Hawthorne, CA, US - Received
- August 4, 1987
- Decision date
- October 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080459 | Chromesytems Toxicology Calibrators and ControlsLAS · Abbreviated | Chromsystems Instruments & Chemicals GmbH | 11/17/2009SE |
| K072257 | Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-LEVELLAS · Traditional | More Diagnostics | 01/30/2008SE |
| K062942 | Quantimetrix Nicosure Cotinine Urine ControlLAS · Traditional | Quantimetrix Corp. | 10/30/2006SE |
| K051074 | Mas Immunosuppressant ControlsLAS · Traditional | Microgenics Corp. | 06/06/2005SE |
| K040411 | Dri Oxycodone AssayLAS · Traditional | Microgenics Corp. | 05/27/2004SE |
| K032842 | Microgenics Cyclosporine Control KitLAS · Traditional | Microgenics Corp. | 10/17/2003SE |
| K030616 | Cedia Cyclosporine Plus High Range Controls 4 and 5LAS · Traditional | Microgenics Corp. | 03/31/2003SE |
| K992151 | Reference Material for DELTA-9-THC-COOH in Human UrineLAS · Traditional | Consolidated Technologies, Inc. | 07/14/1999SE |
| K970517 | Innofluor Topiramate Control SetLAS · Traditional | Oxis Intl., Inc. | 05/12/1997SE |
| K971210 | Synchron Systems 10 Ng/Ml & 40 Ng/Ml THC Urine ControlsLAS · Traditional | Beckman Instruments, Inc. | 04/17/1997SE |
More from Beckman Instruments, Inc.
| 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 |
| K874302 | Quantimetrix Total Creatine Kinase ControlJJT · Traditional | 02/02/1988SE |
| K874890 | Quantimetrix Urine Dipstick ControlJJW · Traditional | 01/21/1988SE |
| 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 Serum Alcohol Control Level 1 and 2 cleared by the FDA?
Quantimetrix Serum Alcohol Control Level 1 and 2 (K873011) received a 510(k) decision of Substantially Equivalent on October 29, 1987, 86 days after the submission was received.
What is the product code of K873011?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.