Colormate TLC Bilitest System
FDA 510(k) K001687 · Chromatics Color Sciences Intl., Inc.
510(k) numberK001687
Submission
- Device name
- Colormate TLC Bilitest System
- Applicant
- Chromatics Color Sciences Intl., Inc.
Rockville, MD, US - Received
- June 1, 2000
- Decision date
- September 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQM – Bilirubin (Total And Unbound) In The Neonate Test System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1113
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170882 | ABL90 Flex, ABL90 Flex PlusMQM · Traditional | Radiometer Medical Aps | 04/28/2017SE |
| K133175 | Draeger Jaundice Meter JM-105MQM · Traditional | Draeger Medical Systems, Inc. | 11/13/2014SE |
| K132691 | ABL90 FlexMQM · Traditional | Radiometer Medical Aps | 11/13/2014SE |
| K110277 | Rapidpoint 405 Neonatal BilirubinMQM · Traditional | Siemens Healthcare Diagnostics | 08/15/2011SE |
| K073537 | Neonatal Bilirubin on Rapidlab Models 1245 and 1265MQM · Traditional | Siemens Medical Solutions Diagnostics | 06/27/2008SE |
| K042522 | Jaundice Meter, Model JM 103MQM · Traditional | Draeger Medical Infant Care, Inc. | 07/06/2005SE |
| K040174 | Bilirubin Assay on the Omni S AnalyzerMQM · Traditional | Roche Diagnostics Corp. | 05/14/2004SE |
| K021622 | Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103MQM · Traditional | Hill-Rom Air-Shields | 04/01/2003SE |
| K010052 | Respironics Bilichek NON-INVASIVE-100-0800-20; Bilirubin AnalyzerMQM · Abbreviated | Respironics, Inc. | 03/19/2001SE |
| K994438 | Bilichek Non-Invasive Bilirubin AnalyzerMQM · Traditional | Spectrx, Inc. | 02/04/2000SE |
More from Spectrx, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964590 | Colormate IIIMQM · Traditional | 07/24/1997SE |
Questions and answers
When was Colormate TLC Bilitest System cleared by the FDA?
Colormate TLC Bilitest System (K001687) received a 510(k) decision of Substantially Equivalent on September 13, 2001, 469 days after the submission was received.
What is the product code of K001687?
The FDA product code is MQM – Bilirubin (Total And Unbound) In The Neonate Test System, a Class I (low risk) device regulated under 21 CFR 862.1113.