Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21
FDA 510(k) K010734 · Branan Medical Corp.
510(k) numberK010734
Submission
- Device name
- Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21
- Applicant
- Branan Medical Corp.
Irvine, CA, US - Received
- March 12, 2001
- Decision date
- July 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MLK – Thin Layer Chromatography, Tricyclic Antidepressant Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3910
- Specialty
- Clinical Toxicology
Other 510(k)s with product code MLK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022693 | Instant-View Tca Urine TestMLK · Abbreviated | Alfa Scientific Designs, Inc. | 12/09/2002SE |
More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K122633 | Toxcup Drug Screen CupLDJ · Traditional | 02/07/2013SE |
| K122752 | Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…JXN · Traditional | 01/30/2013SE |
| K103227 | Oratect Oral Fluid Drug Screen DevicesDIO · Traditional | 04/11/2012SE |
| K082508 | Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen DipcardDJG · Traditional | 11/21/2008SE |
| K040203 | Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect II Mdma Drug Screen…DKZ · Traditional | 03/25/2004SE |
| K032057 | Toxcup Drug Screen Cup Amp/Coc/Met/Opi/Pcp/ThcDIO · Special | 08/21/2003SE |
| K030113 | Monitect Oxycodone Drug Screen Cassette Test, Model MC 23, Fastect Oxycodone Drug Screen…DJG · Traditional | 07/02/2003SE |
| K023489 | Quicktox Multiple Drug DipcardDIO · Special | 12/16/2002SE |
| K022355 | Quicktox Multiple Drug Dipcard Coc/Met/Thc/Amp/Pcp/Bzo/Bar/Mtd/Tca, Model QT61DIO · Special | 07/30/2002SE |
| K013124 | Modification to Scooper Drug/Adulteration Test CupDJJ · Special | 11/07/2001SE |
Questions and answers
When was Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21 cleared by the FDA?
Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21 (K010734) received a 510(k) decision of Substantially Equivalent on July 30, 2001, 140 days after the submission was received.
What is the product code of K010734?
The FDA product code is MLK – Thin Layer Chromatography, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.