I.V. Start Kit
FDA 510(k) K780222 · Marion Laboratories, Inc.
510(k) numberK780222
Submission
- Device name
- I.V. Start Kit
- Applicant
- Marion Laboratories, Inc.
Mchenry, IL, US - Received
- February 9, 1978
- Decision date
- March 28, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
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Questions and answers
When was I.V. Start Kit cleared by the FDA?
I.V. Start Kit (K780222) received a 510(k) decision of Substantially Equivalent on March 28, 1978, 47 days after the submission was received.
What is the product code of K780222?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.