Titan Ge/Ieplate
FDA 510(k) K831603 · Helena Laboratories
510(k) numberK831603
Submission
- Device name
- Titan Ge/Ieplate
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- May 18, 1983
- Decision date
- July 7, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K940037 | I.D. and Seakem GTG AgarosesJZR · Traditional | Fmc Corp. | 02/24/1995SE |
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Questions and answers
When was Titan Ge/Ieplate cleared by the FDA?
Titan Ge/Ieplate (K831603) received a 510(k) decision of Substantially Equivalent on July 7, 1983, 50 days after the submission was received.
What is the product code of K831603?
The FDA product code is JZR – Support Gels, a Class I (low risk) device regulated under 21 CFR 866.4900.