Immulite 2000 Folic Acid, Model L2KF02, L2KF06
FDA 510(k) K993254 · Diagnostic Products Corp.
510(k) numberK993254
Submission
- Device name
- Immulite 2000 Folic Acid, Model L2KF02, L2KF06
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- September 28, 1999
- Decision date
- November 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGN – Acid, Folic, Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1295
- Specialty
- Clinical Chemistry
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Questions and answers
When was Immulite 2000 Folic Acid, Model L2KF02, L2KF06 cleared by the FDA?
Immulite 2000 Folic Acid, Model L2KF02, L2KF06 (K993254) received a 510(k) decision of Substantially Equivalent on November 12, 1999, 45 days after the submission was received.
What is the product code of K993254?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.