I.D. and Seakem GTG Agaroses
FDA 510(k) K940037 · Fmc Corp.
510(k) numberK940037
Submission
- Device name
- I.D. and Seakem GTG Agaroses
- Applicant
- Fmc Corp.
Washington, DC, US - Received
- January 4, 1994
- Decision date
- February 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JZR – Support Gels
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4900
- Specialty
- Immunology
Other 510(k)s with product code JZR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831603 | Titan Ge/IeplateJZR · Traditional | Helena Laboratories | 07/07/1983SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K841407 | Isogel AgaroseJJN · Traditional | 07/16/1985SE |
Questions and answers
When was I.D. and Seakem GTG Agaroses cleared by the FDA?
I.D. and Seakem GTG Agaroses (K940037) received a 510(k) decision of Substantially Equivalent on February 24, 1995, 416 days after the submission was received.
What is the product code of K940037?
The FDA product code is JZR – Support Gels, a Class I (low risk) device regulated under 21 CFR 866.4900.