Rep Spe Hi-Res System No. 3176, 3177, 3178
FDA 510(k) K892424 · Helena Laboratories
510(k) numberK892424
Submission
- Device name
- Rep Spe Hi-Res System No. 3176, 3177, 3178
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- April 10, 1989
- Decision date
- June 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Rep Spe Hi-Res System No. 3176, 3177, 3178 cleared by the FDA?
Rep Spe Hi-Res System No. 3176, 3177, 3178 (K892424) received a 510(k) decision of Substantially Equivalent on June 9, 1989, 60 days after the submission was received.
What is the product code of K892424?
The FDA product code is CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.