Lyophilized Vials of Vca and Vcat
FDA 510(k) K780306 · Gibco Laboratories Life Technologies, Inc.
510(k) numberK780306
Submission
- Device name
- Lyophilized Vials of Vca and Vcat
- Applicant
- Gibco Laboratories Life Technologies, Inc.
Mchenry, IL, US - Received
- February 23, 1978
- Decision date
- March 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSK – Supplement, Culture Media
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2450
- Specialty
- Microbiology
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| K863289 | CDC Anaerobic Agar W/Sheep Blood, Kana-&VancomycinJSJ · Traditional | 09/03/1986SE |
| K862425 | Macconkey Agar W/Mug, Dri-Form and Pre-FormJSI · Traditional | 07/02/1986SE |
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Questions and answers
When was Lyophilized Vials of Vca and Vcat cleared by the FDA?
Lyophilized Vials of Vca and Vcat (K780306) received a 510(k) decision of Substantially Equivalent on March 17, 1978, 22 days after the submission was received.
What is the product code of K780306?
The FDA product code is JSK – Supplement, Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2450.