Polyslit Ife Kit
FDA 510(k) K990998 · Helena Laboratories
510(k) numberK990998
Submission
- Device name
- Polyslit Ife Kit
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- March 25, 1999
- Decision date
- June 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Polyslit Ife Kit cleared by the FDA?
Polyslit Ife Kit (K990998) received a 510(k) decision of Substantially Equivalent on June 28, 1999, 95 days after the submission was received.
What is the product code of K990998?
The FDA product code is CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.