Urine Cultur Stabilization Transport Tube
FDA 510(k) K920761 · Bio Medicus, Inc.
510(k) numberK920761
Submission
- Device name
- Urine Cultur Stabilization Transport Tube
- Applicant
- Bio Medicus, Inc.
Rockaway, NJ, US - Received
- February 19, 1992
- Decision date
- June 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LIO – Device, Specimen Collection
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
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| K884129 | Bio-Medicus Percutaneous Cannula & Introducer SetDQY · Traditional | 12/21/1988SE |
| K883956 | Bio-Medicus Tubing ConnectorsDTL · Traditional | 10/28/1988SE |
| K872033 | Bio-Medicus Cannula-TubingDWF · Traditional | 12/07/1987SE |
| K861096 | Cardiopulmonary Cannula TubingDWF · Traditional | 05/21/1986SE |
| K854133 | Bio Medicus Bio Console 540DWA · Traditional | 01/08/1986SE |
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Questions and answers
When was Urine Cultur Stabilization Transport Tube cleared by the FDA?
Urine Cultur Stabilization Transport Tube (K920761) received a 510(k) decision of Substantially Equivalent on June 19, 1992, 121 days after the submission was received.
What is the product code of K920761?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.