MAK-6 Monoclonal Anti-Cytokeratin Cocktail
FDA 510(k) K881259 · Triton Biosciences, Inc.
510(k) numberK881259
Submission
- Device name
- MAK-6 Monoclonal Anti-Cytokeratin Cocktail
- Applicant
- Triton Biosciences, Inc.
Alameda, CA, US - Received
- March 23, 1988
- Decision date
- October 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYE – Cytokeratins
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code LYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K864893 | Anti-Cytokeratin Monoclonal AntibodyLYE · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/07/1988SE |
Questions and answers
When was MAK-6 Monoclonal Anti-Cytokeratin Cocktail cleared by the FDA?
MAK-6 Monoclonal Anti-Cytokeratin Cocktail (K881259) received a 510(k) decision of Substantially Equivalent on October 12, 1988, 203 days after the submission was received.
What is the product code of K881259?
The FDA product code is LYE – Cytokeratins, a Class II (moderate risk) device regulated under 21 CFR 866.5550.