Active Inhibin-A Elisa, Model DSL-10-28100
FDA 510(k) K002128 · Diagnostic Systems Laboratories, Inc.
510(k) numberK002128
Submission
- Device name
- Active Inhibin-A Elisa, Model DSL-10-28100
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- July 14, 2000
- Decision date
- December 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDR – Enzyme Immunoassay, Inhibin-A
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1260
- Specialty
- Clinical Chemistry
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Questions and answers
When was Active Inhibin-A Elisa, Model DSL-10-28100 cleared by the FDA?
Active Inhibin-A Elisa, Model DSL-10-28100 (K002128) received a 510(k) decision of Substantially Equivalent on December 5, 2000, 144 days after the submission was received.
What is the product code of K002128?
The FDA product code is NDR – Enzyme Immunoassay, Inhibin-A, a Class I (low risk) device regulated under 21 CFR 862.1260.